CompletedNCT00190983Updated Nov 20, 2009Results posted

A Trial for Patients With Advanced/Recurrent Cervical Cancer

A Phase 2 interventional study of Pemetrexed in Cervical Intraepithelial Neoplasia, Uterine Neoplasms and Genital Neoplasms, Female, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2009-11-20.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 29
Allocation: Non-randomized
Sex: Female

Study summary

This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.

Conditions studied

Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female

Browse trials for

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 29 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

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

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
Measurable disease
Gynecologic Oncology Group (GOG) performance status 0-2
Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy

Exclusion criteria

Exclusion Criteria:

Prior Pemetrexed
Patients who have received radiation to more than 25% of marrow bearing areas
Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Experimental
Pemetrexed
Drug: Pemetrexed

Interventions

DrugPemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.

What researchers measure

Primary outcomes

Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Time frame: baseline to measured progressive disease (up to 5 years)

Secondary outcomes

Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time frame: time of initial response until documented tumor progression (up to 5 years)
Progression-Free Survival
The period from study entry until disease progression, death or date of last contact.
Time frame: baseline until documented tumor progression (up to 5 years)
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: baseline until death from any cause (up to 5 years)

Results

Posted Aug 24, 2009

Participant flow

Participant flow — Overall Study
Milestone	Pemetrexed
Started	29
Completed	27
Not completed	2
Withdrew: Inevaluable (never treated)	2

Outcome measures

PrimaryTumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Time frame:: baseline to measured progressive disease (up to 5 years)
Reported as:: Number · participants

Tumor Response
participants	Pemetrexed
Complete Response	0
Partial Response	4
Stable Disease	16
Disease Progression	7

SecondaryDuration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

Time frame:: time of initial response until documented tumor progression (up to 5 years)
Reported as:: Median · months

Duration of Response
months	Pemetrexed
Duration of Response	4.4 (4.2 to 33.7)

SecondaryProgression-Free Survival

The period from study entry until disease progression, death or date of last contact.

Time frame:: baseline until documented tumor progression (up to 5 years)
Reported as:: Median · months

Progression-Free Survival
months	Pemetrexed
Progression-Free Survival	3.1 (0.9 to 23.7)

SecondaryOverall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Time frame:: baseline until death from any cause (up to 5 years)
Reported as:: Median · months

Overall Survival
months	Pemetrexed
Overall Survival	7.4 (1.4 to 23.7)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pemetrexed	—	—	—

Most frequent serious events

Most frequent serious events
Event	Pemetrexed
Febrile neutropeniaBlood and lymphatic system disorders	1/27
ThrombocytopeniaBlood and lymphatic system disorders	1/27
Gastrointestinal haemorrhageGastrointestinal disorders	1/27
PyelonephritisInfections and infestations	1/27
Blood alkaline phosphatase increasedInvestigations	1/27
Haemoglobin decreasedInvestigations	1/27
White blood cell count decreasedInvestigations	1/27
HypoalbuminaemiaMetabolism and nutrition disorders	1/27
HypocalcaemiaMetabolism and nutrition disorders	1/27
Female genital tract fistulaReproductive system and breast disorders	1/27

Most frequent other events

Showing 10 of 22

Most frequent other events
Event	Pemetrexed
AnemiaBlood and lymphatic system disorders	23/27
ConstitutionalGeneral disorders	21/27
MetabolicMetabolism and nutrition disorders	20/27
LeukopeniaBlood and lymphatic system disorders	19/27
NeutropeniaBlood and lymphatic system disorders	17/27
GastrointestinalGastrointestinal disorders	16/27
Nausea/vomitingGastrointestinal disorders	13/27
PainGeneral disorders	12/27
InfectionInfections and infestations	12/27
Alkaline phosphataseInvestigations	11/27

Baseline characteristics

Age, Customized
Age, Customized(participants)	Pemetrexed
<40 years	6
40-49 years	9
50-59 years	7
60-69 years	4
>69 years	1

Sex: Female, Male
Sex: Female, Male(Participants)	Pemetrexed
Female	27
Male	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Pemetrexed
White	24
Black	2
Asian	1

Region of Enrollment
Region of Enrollment(participants)	Pemetrexed
United States	27

Cell Type
Cell Type(participants)	Pemetrexed
Squamous	19
Adenocarcinoma	6
Clear cell	1
Adenosquamous	1

Gynecologic Oncology Group (GOG) Performance Status
Gynecologic Oncology Group (GOG) Performance Status(participants)	Pemetrexed
0 - Fully active	16
1 - Ambulatory, Restricted Strenuous Activity	9
2 - Ambulatory, No Work Activities	2

Prior Therapy
Prior Therapy(participants)	Pemetrexed
Prior Chemotherapy	27
No Prior Chemotherapy	0
Prior Radiotherapy	23
No Prior Radiotherapy	4

Tumor Grade
Tumor Grade(participants)	Pemetrexed
G1 - Well-Differentiated	5
G2 - Moderately Differentiated	15
G3 - Poorly Differentiated	5
Unspecified	2

Study locations

1 site

Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00190983
Lead sponsor: Eli Lilly and Company
Collaborators: Gynecologic Oncology Group
First posted: Sep 19, 2005
Start date: Feb 2005
Primary completion: Oct 2007
Completion: Oct 2007
Results posted: Aug 24, 2009
Last update: Nov 20, 2009

Study contacts

David Miller, MD

study chair · Gynecologic Oncology Group

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Eli Lilly and Company

Start the discussion