A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.

Official Title
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A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma

Conditions
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Ovarian Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer Measurable disease Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population) Exclusion Criteria: Patients who have had prior therapy with pemetrexed Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. Patients who have received radiation to more than 25% of marrow
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed<br> | Drug: pemetrexed<br>* 900 mg/m2, intravenous (IV), every 21 days, until disease progression<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria. | baseline to measured progressive disease (up to 44 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events by Grade | Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported. | every 21-day cycle up to 5 year follow-up | 
| 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 of initial response until documented tumor progression (up to 44 months) | 
| Progression-Free Survival | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | baseline until documented tumor progression (up to 44 months) | 
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | baseline until death from any cause up to 5-year follow-up |