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Active, not recruitingNCT02595879Updated Jul 31, 2026Results posted

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer

A Phase 1 interventional study of Biospecimen Collection and Brachytherapy in Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma and Advanced Cervical Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 17 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerable dose (MTD) and recommended phase II dose (RP2D) of oral triapine when used in combination with cisplatin plus radiation therapy.

II. To determine the oral bioavailability of triapine. III. To describe the pharmacokinetics (PK) of oral and intravenous triapine.

SECONDARY OBJECTIVES:

I. To determine whether the metabolic complete response (mCR) rate of oral triapine in combination with cisplatin chemoradiation using fludeoxyglucose F 18 (18F-FDG)-positron emission tomography (PET)/computed tomography (CT) at post-therapy (3-month) is at least 70%.

II. To determine clinical overall response rate, progression-free survival, and overall survival.

III. To determine the correlation of methemoglobin proportion (%) and triapine pharmacokinetic exposure.

EXPLORATORY OBJECTIVE:

I. To determine whether active human immunodeficiency virus (HIV) antiretroviral therapy impacts the antitumor activity of triapine.

OUTLINE: This is a dose-escalation study of triapine.

Patients undergo pelvic external beam radiation therapy (EBRT) or intensity modulated radiation therapy (IMRT) 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of low dose rate (LDR) brachytherapy in week 6 or 5 fractions of high dose rate (HDR) brachytherapy at week 4 or 5. Patients also receive triapine intravenously (IV) over 120 minutes on day 1 and orally (PO) on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo magnetic resonance imaging (MRI) and FDG-PET/CT during follow-up.

02

Conditions studied

  • Advanced Cervical Adenocarcinoma
  • Advanced Cervical Adenosquamous Carcinoma
  • Advanced Cervical Squamous Cell Carcinoma
  • Advanced Vaginal Adenocarcinoma
  • Advanced Vaginal Adenosquamous Carcinoma
  • Advanced Vaginal Squamous Cell Carcinoma
  • Stage IB2 Cervical Cancer AJCC v6 and v7
  • Stage II Cervical Cancer AJCC v7
  • Stage II Vaginal Cancer AJCC v6 and v7
  • Stage III Vaginal Cancer AJCC v6 and v7
  • Stage IIIB Cervical Cancer AJCC v6 and v7
  • Stage IVA Cervical Cancer AJCC v6 and v7
  • Stage IVA Vaginal Cancer AJCC v6 and v7
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has a new, untreated histologic diagnosis of stage IB2 (> 5 cm), II, IIIB, IIIC or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
  • Age >= 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Life expectancy greater than 6 months
  • Absolute neutrophil count (ANC) >= 1.5 x 10\^9/L
  • Platelets >= 100 x 10\^9/L
  • Hemoglobin (Hgb) >= 10.0 g/dL (blood transfusions to reach this amount are allowed)

  • Serum creatinine =\< 1.5 mg/dL to receive weekly cisplatin

    • If serum creatinine is between 1.5 and 1.9 mg/dL, patients are eligible for cisplatin if the estimated creatinine clearance (CCr) is > 30 ml/min (for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used)
  • Total serum bilirubin =\< 1.5 x upper limit of normal (ULN) (in patients with known Gilbert syndrome, a total bilirubin =\< 3.0 x ULN, with direct bilirubin =\< 1.5 x ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
  • Able to take oral medication
  • Not pregnant and not breastfeeding; the effects of triapine on the developing human fetus are unknown; for this reason as well as because heterocyclic carboxaldehydethiosemicarbazones and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; patient must have documented negative urine pregnancy test must be resulted within 7 days before initiating protocol therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine; these potential risks may also apply to other agents used in this study

  • For HIV and hepatitis B/C (HEPB/C):

    • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for the dose escalation portion of this trial; for those patients who are enrolled in the HIV positive (+) expansion cohort, they must be HIV infected and be on retroviral therapy with an undetectable viral load within 6 months of enrollment
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured; for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Able to understand and willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix)
  • Patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
  • Patients receiving any other investigational agents
  • Patients with known glucose-6-phosphate dehydrogenase deficiency (G6PD) are excluded due to an inability to administer the antidote for methemoglobinemia, methylene blue; pre-registration testing for G6PD is at the investigator's discretion and is not required for study enrollment
  • Patients who are taking any medication associated with methemoglobinemia; medication must be discontinued and must have a washout period of 4 halflives or 4 weeks, whichever is shorter
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or cisplatin
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =\< 200 mg/dL allowed)
  • Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible
  • Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Treatment (triapine, chemoradiation)

    Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.

    Procedure: Biospecimen Collection · Radiation: Brachytherapy · Drug: Cisplatin · Procedure: Computed Tomography · Radiation: External Beam Radiation Therapy · Other: Fludeoxyglucose F-18 · Radiation: High-Dose Rate Brachytherapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Other: Pharmacological Study · Procedure: Positron Emission Tomography · Drug: Triapine

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • RadiationBrachytherapy

    Undergo LDR brachytherapy

    Also known as: Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy, Radiation, Internal

  • DrugCisplatin

    Given IV

    Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

  • ProcedureComputed Tomography

    Undergo FDG-PET/CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • RadiationExternal Beam Radiation Therapy

    Undergo pelvic EBRT

    Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation

  • OtherFludeoxyglucose F-18

    Undergo FDG-PET/CT

    Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

  • RadiationHigh-Dose Rate Brachytherapy

    Undergo HDR brachytherapy

    Also known as: Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)

  • RadiationIntensity-Modulated Radiation Therapy

    Undergo IMRT

    Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • OtherPharmacological Study

    Correlative studies

  • ProcedurePositron Emission Tomography

    Undergo FDG-PET/CT

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • DrugTriapine

    Given IV and PO

    Also known as: 3-aminopyridine-2-carboxaldehyde thiosemicarbazone, 3-AP, 3-Apct, OCX-0191, OCX-191, OCX191, PAN-811

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD

    Time frame: Up to 5 weeks

  2. Number of Patients Who Experienced a DLT

    Number of patients that experienced a DLT, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLTs are defined as the following adverse events if considered at least "possibly related" to a component of the study therapy and which occur from the start of treatment until completion of EBRT, prior to initiation of brachytherapy (i.e. the first 5 weeks if no treatments are missed): Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 3 toxicity not resolved with maximal intervention to Grade 0-2 over 7 days (except alopecia and fatigue); Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 4 toxicity; Any other non-hematologic toxicity ≥Grade 3; Any hematologic toxicity of ≥ Grade 4; Grade ≥3 dyspnea; Inability to deliver at least 20 of the scheduled 25 administrations of triapine at the planned dose, allowing for 2 weeks to make up missed radiation days. Inability to deliver

    Time frame: Up to 5 weeks

  3. Bioavailability of Triapine

    The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.

    Time frame: Up to 2 weeks

  4. Cmax

    Maximum concentration

    Time frame: Up to 24 hours after dosing

  5. Tmax

    Time to maximum concentration,

    Time frame: Up to 24 hours after dosing

  6. AUC

    Area Under the Concentration-Time Curve (AUC 0-last)

    Time frame: Up to 24 hours after dosing

  7. Elimination Half-life (t 1/2)

    Time frame: Up to 24 hours after dosing

Secondary outcomes

  1. Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate

    The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool).

    Time frame: At 3 months post-treatment

  2. Clinical Overall Response Rate

    Clinical response at the recommended phase 2 dose per RECIST v1.1 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Time frame: 3 months post-treatment

  3. Progression Free Survival (PFS)

    Median number of months that patients survive without disease progression from end of treatment. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Time frame: Up to 4 years and 2 months from start of treatment

  4. Overall Survival (OS)

    Median number of months that patients remain alive after end of treatment.

    Time frame: Up to 4 years and 2 months from start of treatment

07

Results

Posted Oct 16, 2024

Participant flow

Cohort 1 / Dose Level 1
Participant flow — Cohort 1 / Dose Level 1
Milestone100 mg PO Triapine + Chemoradiation150 mg PO Triapine + Chemoradiation
Started30
Completed30
Not completed00
Cohort 2 / Dose Level 2
Participant flow — Cohort 2 / Dose Level 2
Milestone100 mg PO Triapine + Chemoradiation150 mg PO Triapine + Chemoradiation
Started04
Completed04
Not completed00
Cohort 3 / Dose Level 1
Participant flow — Cohort 3 / Dose Level 1
Milestone100 mg PO Triapine + Chemoradiation150 mg PO Triapine + Chemoradiation
Started30
Completed30
Not completed00
Expansion Cohort
Participant flow — Expansion Cohort
Milestone100 mg PO Triapine + Chemoradiation150 mg PO Triapine + Chemoradiation
Started110
Completed100
Not completed10
Withdrew: Did not complete treatment regimen10

Outcome measures

PrimaryMaximum Tolerated Dose (MTD)

The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD

Time frame:
Up to 5 weeks
Reported as:
Number · mg
Maximum Tolerated Dose (MTD)
mgAll Participants
Maximum Tolerated Dose (MTD)100
PrimaryNumber of Patients Who Experienced a DLT

Number of patients that experienced a DLT, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLTs are defined as the following adverse events if considered at least "possibly related" to a component of the study therapy and which occur from the start of treatment until completion of EBRT, prior to initiation of brachytherapy (i.e. the first 5 weeks if no treatments are missed): Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 3 toxicity not resolved with maximal intervention to Grade 0-2 over 7 days (except alopecia and fatigue); Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 4 toxicity; Any other non-hematologic toxicity ≥Grade 3; Any hematologic toxicity of ≥ Grade 4; Grade ≥3 dyspnea; Inability to deliver at least 20 of the scheduled 25 administrations of triapine at the planned dose, allowing for 2 weeks to make up missed radiation days. Inability to deliver

Time frame:
Up to 5 weeks
Reported as:
Count of participants · Participants
Number of Patients Who Experienced a DLT
ParticipantsTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Number of Patients Who Experienced a DLT12
PrimaryBioavailability of Triapine

The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.

Time frame:
Up to 2 weeks
Reported as:
Geometric mean · percentage
Bioavailability of Triapine
percentageTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Bioavailability of Triapine60 (16 to 229)54 (15 to 200)
PrimaryCmax

Maximum concentration

Time frame:
Up to 24 hours after dosing
Reported as:
Geometric mean · ug/L
Cmax
ug/LTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Cmax476 ± 1.90344 ± 1.91
PrimaryTmax

Time to maximum concentration,

Time frame:
Up to 24 hours after dosing
Reported as:
Geometric mean · hours
Tmax
hoursTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Tmax0.9 ± 3.01.5 ± 1.5
PrimaryAUC

Area Under the Concentration-Time Curve (AUC 0-last)

Time frame:
Up to 24 hours after dosing
Reported as:
Geometric mean · ug/L x h
AUC
ug/L x hTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
AUC990 ± 2.09990 ± 1.42
PrimaryElimination Half-life (t 1/2)
Time frame:
Up to 24 hours after dosing
Reported as:
Geometric mean · hours
Elimination Half-life (t 1/2)
hoursTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Elimination Half-life (t 1/2)1.5 ± 1.31.5 ± 1.3
SecondaryFludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate

The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool).

Time frame:
At 3 months post-treatment
Reported as:
Number · percentage response-evaluable patients
Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate
percentage response-evaluable patientsTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate62 (30 to 86)100 (32 to 100)
SecondaryClinical Overall Response Rate

Clinical response at the recommended phase 2 dose per RECIST v1.1 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame:
3 months post-treatment
Reported as:
Number · percentage response evaluable patient
Clinical Overall Response Rate
percentage response evaluable patientTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Complete Response62 (30 to 86)100 (32 to 100)
Partial Response15 (3 to 50)0 (0 to 68)
Stable Disease15 (3 to 50)0 (0 to 68)
Progressive Disease8 (1 to 42)0 (0 to 68)
SecondaryProgression Free Survival (PFS)

Median number of months that patients survive without disease progression from end of treatment. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Time frame:
Up to 4 years and 2 months from start of treatment
Reported as:
Median · months
Progression Free Survival (PFS)
monthsTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Progression Free Survival (PFS)NA (NA to NA)NA (NA to NA)
SecondaryOverall Survival (OS)

Median number of months that patients remain alive after end of treatment.

Time frame:
Up to 4 years and 2 months from start of treatment
Reported as:
Median · months
Overall Survival (OS)
monthsTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Overall Survival (OS)NA (NA to NA)NA (NA to NA)

Adverse events

Collected over Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Triapine (100mg) + Chemoradiation)0/17 (0%)8/17 (47.1%)17/17 (100%)
Triapine (150mg) + Chemoradiation)0/4 (0%)2/4 (50%)4/4 (100%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
Vascular access complicationInjury, poisoning and procedural complications0/171/4
MethemoglobinemiaInvestigations1/171/4
HypoxiaRespiratory, thoracic and mediastinal disorders1/171/4
Decreased plateletsBlood and lymphatic system disorders2/170/4
HypokalemiaMetabolism and nutrition disorders2/170/4
AnemiaBlood and lymphatic system disorders1/170/4
Sinus tachycardiaCardiac disorders1/170/4
Urinary tract infectionInfections and infestations1/170/4
Neutrophil count decreasedInvestigations1/170/4
White blood cell decreasedInvestigations1/170/4
Most frequent other events
Showing 10 of 112
Most frequent other events
EventTriapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)
NauseaGastrointestinal disorders15/174/4
FatigueGeneral disorders13/174/4
Lymphocyte count decreasedInvestigations15/174/4
AnemiaBlood and lymphatic system disorders16/173/4
DiarrheaGastrointestinal disorders16/173/4
White blood cell decreasedInvestigations14/173/4
Decreased plateletsBlood and lymphatic system disorders13/173/4
Neutrophil count decreasedInvestigations13/173/4
VomitingGastrointestinal disorders11/173/4
MethemoglobinemiaInvestigations10/173/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
Median51.0 (23.0 to 71.0)46.5 (35.0 to 56.0)51.0 (23.0 to 71.0)
Sex: Female, Male
Sex: Female, Male(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
Female17421
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
Hispanic or Latino101
Not Hispanic or Latino15419
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White15419
More than one race000
Unknown or Not Reported202
Smoking History
Smoking History(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
Yes516
No12214
Unknown011
Primary Site
Primary Site(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
Cervix15419
Vagina202
Histology
Histology(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
adenocarcinoma325
squamous cell carcinoma13215
adenosquamous101
Stage at Diagnosis
Stage at Diagnosis(Participants)Triapine (100mg) + Chemoradiation)Triapine (150mg) + Chemoradiation)Total
Stage IB112
Stage II112
Stage IIA101
Stage IIB303
Stage III112
Stage IIIB101
Stage IIIC718
Stage IVA202

2 further baseline measures are reported on the registry.

08

Study locations

17 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Keck Medical Center of USC Pasadena
    Pasadena, California 91105, United States
  • University of Kansas Clinical Research Center
    Fairway, Kansas 66205, United States
  • University of Kansas Cancer Center
    Kansas City, Kansas 66160, United States
  • University of Kansas Hospital-Indian Creek Campus
    Overland Park, Kansas 66211, United States
  • University of Kansas Hospital-Westwood Cancer Center
    Westwood, Kansas 66205, United States
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
  • University of Michigan Rogel Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Weisberg Cancer Treatment Center
    Farmington Hills, Michigan 48334, United States
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
  • VCU Massey Comprehensive Cancer Center
    Richmond, Virginia 23298, United States
09

References and documents

Publications

  • Taylor SE, Behr S, Cooper KL, Mahdi H, Fabian D, Gallion H, Ueland F, Vargo J, Orr B, Girda E, Courtney-Brooks M, Olawaiye AB, Randall LM, Richardson DL, Sullivan SA, Huang M, Christner SM, Beriwal S, Lin Y, Chauhan A, Chu E, Kohn EC, Kunos C, Ivy SP, Beumer JH. Dose finding, bioavailability, and PK-PD of oral triapine with concurrent chemoradiation for locally advanced cervical cancer and vaginal cancer (ETCTN 9892). Cancer Chemother Pharmacol. 2024 Dec 14;95(1):4. doi: 10.1007/s00280-024-04720-1. PubMed 39673591 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02595879
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 4, 2015
Start date
Sep 18, 2019
Primary completion
Jun 4, 2023
Completion
Apr 29, 2027 (estimated)
Results posted
Oct 16, 2024
Last update
Jul 31, 2026

Study contacts

Sarah E Taylor
principal investigator · University of Pittsburgh Cancer Institute LAO

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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