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TerminatedNCT01659554HIPECUpdated Mar 10, 2017Results posted

A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers

A Phase 2 interventional study of Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Fallopian Tube Cancer, sponsored by Columbia University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by Columbia University · Phase 2, Interventional, and Treatment

Why this study was terminated
Principal Investigator left institution
Phase
Phase 2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.

Read the detailed description

This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.

02

Conditions studied

  • Recurrent Ovarian Cancer
  • Fallopian Tube Cancer

Keywords

  • Primary peritoneal
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

This study's enrollment of 4 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.

Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must have histologically confirmed ovarian, primary peritoneal or fallopian tube carcinoma.
  2. Patients must have measurable evidence of recurrent intraabdominal disease based on Computed tomography (CT scan) findings.
  3. Patients must fulfill the following with regard to prior chemotherapy:

    1. 4 weeks or greater since conclusion of prior chemotherapy;
    2. Prior intraperitoneal chemotherapy with cisplatin is acceptable; and,
    3. Prior systemic chemotherapy is acceptable.
  4. Patients must have a Karnofsky Performance Status of > 70%
  5. Patients must have an estimated life expectancy of at least 16 weeks.
  6. Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.
  7. Patients must have adequate organ function at the screening visit as defined by the following laboratory values:

    Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥8 g/dL Albumin ≥ 2 g/dL Total Bilirubin ≤ 2.5 x ULN* Alkaline phosphatase ≤ 3.0 x ULN* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN Creatinine ≤ 1.5 x ULN

  8. Patient must have signed informed consent
  9. Patient must be at least 18 years of age
  10. Following cytoreductive surgery, patient's residual disease should be no larger than 1cm to Receive HIPEC and continue with normothermic IP chemotherapy

Exclusion criteria

Exclusion criteria:

  1. Have active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 4).
  2. Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure (see section 16.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  3. Prior radiation therapy within 4 weeks of enrollment.
  4. Have uncontrolled active systemic infection requiring therapy.
  5. Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
  6. Have had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
  7. Have had a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
  8. Have had any investigational agent within 4 weeks before enrollment into the study.
  9. Have a history of a serious medical or psychiatric illness preventing informed consent or, in the opinion of the investigator, would make the patient a poor study candidate.
  10. Evidence of extraabdominal metastasis on preinclusion thoracic computed tomography (CT) scans (i.e. brain or chest disease).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Out-Patient Intraperitoneal Chemotherapy

    Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle.

    Drug: Cisplatin · Drug: Doxorubicin

Interventions

  • Cisplatin (75 mg/m2) prepared in 2L normal saline.

    Also known as: cis-diamminedichloroplatinum(II) (CDDP), Platinol, Platinol-AQ

  • Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).

    Also known as: hydroxyldaunorubicin, Adriamycin

06

What researchers measure

Primary outcomes

  1. Adverse Event Rate and/or Laboratory Changes

    The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.

    Time frame: 5 years

  2. Toxicity Rating Based on NCI Common Toxicity Criteria

    Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).

    Time frame: Up to 5 years

Secondary outcomes

  1. Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)

    Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.

    Time frame: Up to 5 years (survival)

  2. Kaplan-Meier Curves for Patient Overall Survival

    Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).

    Time frame: Up to 5 years, survival

07

Results

Posted Mar 3, 2015
Limitations and caveats
Zero participants analyzed due to early termination of study. Adverse Events could not be collected over the pre-specified Time Frame ("5 years") due to study termination

Participant flow

Subjects were screened and enrolled during 10/23/2012 to 08/20/2013.

Participant flow — Overall Study
MilestoneIntraoperative Cisplatin Followed by IP Chemotherapy
Started4
Completed0
Not completed4
Withdrew: Study termination4

Outcome measures

PrimaryAdverse Event Rate and/or Laboratory Changes

The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.

Time frame:
5 years

No measurements were reported for this outcome.

PrimaryToxicity Rating Based on NCI Common Toxicity Criteria

Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).

Time frame:
Up to 5 years

No measurements were reported for this outcome.

SecondaryTime to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)

Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.

Time frame:
Up to 5 years (survival)

No measurements were reported for this outcome.

SecondaryKaplan-Meier Curves for Patient Overall Survival

Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).

Time frame:
Up to 5 years, survival

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intraoperative Cisplatin Followed by IP Chemotherapy—1/4 (25%)0/4 (0%)
Most frequent serious events
Most frequent serious events
EventIntraoperative Cisplatin Followed by IP Chemotherapy
Ileus, Grade 3Gastrointestinal disorders1/4
Grade 2 Abdominal PainInfections and infestations1/4
IP drain infection, grade 3Infections and infestations1/4
Nausea & vomitingGastrointestinal disorders1/4
No Oliguric Acute Renal InjuryRenal and urinary disorders1/4
Urinary Trasct Infection Grade 3Renal and urinary disorders1/4
Right Shoulder cellulitisInfections and infestations1/4
Fever with catheter related infectionInfections and infestations1/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intraoperative Cisplatin Followed by IP Chemotherapy
<=18 years0
Between 18 and 65 years4
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Intraoperative Cisplatin Followed by IP Chemotherapy
Female4
Male0
Region of Enrollment
Region of Enrollment(participants)Intraoperative Cisplatin Followed by IP Chemotherapy
United States4
08

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01659554
Responsible party
Sponsor
First posted
Aug 8, 2012
Start date
Mar 2012
Primary completion
Apr 2014
Completion
Apr 2014
Results posted
Mar 3, 2015
Last update
Mar 10, 2017

Study contacts

Sharyn Lewin, MD
principal investigator · Columbia University

Oversight

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

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Studies of the drugs tested here: Cisplatin · Doxorubicin

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