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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pemetrexed	pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Tumor Response	baseline to measured progressive disease (up to 44 months)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events by Grade	every 21-day cycle up to 5 year follow-up	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.
Duration of Response	time of initial response until documented tumor progression (up to 44 months)	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.
Progression-Free Survival	baseline until documented tumor progression (up to 44 months)	Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Overall Survival	baseline until death from any cause up to 5-year follow-up	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Philadelphia, Pennsylvania, United States