Completed

A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma

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What is being tested

Data Collection

Who is being recruted

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorGynecologic Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Official TitleA Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma 
NCT00087087
Principal SponsorGynecologic Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent or persistent disease * Measurable disease * At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan * Tumors within a previously irradiated field are considered non-target lesions * Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease * Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel * Platinum-resistant or refractory disease * Treatment-free interval \< 6 months after prior platinum-based therapy OR progressed during platinum-based therapy * Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age * Any age Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN\* * AST and ALT ≤ 3 times ULN\* NOTE: \* ≤ 5 times ULN if due to hepatic metastases Renal * Creatinine clearance ≥ 45 mL/min Other * No other malignancy within the past 5 years except nonmelanoma skin cancer * No neuropathy (sensory or motor) \> grade 1 * No active infection requiring antibiotics * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following: * Monoclonal antibodies * Cytokines * Small-molecule inhibitors of signal transduction * At least 3 weeks since prior biologic or immunologic therapy * At least 24 hours since prior growth factors * No concurrent routine colony-stimulating factors Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens * No prior pemetrexed disodium Endocrine therapy * At least 1 week since prior hormonal therapy for the malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * No prior radiotherapy to \> 25% of bone marrow * At least 2 weeks since prior radiotherapy and recovered Surgery * Recovered from prior surgery Other * No prior cancer treatment that would preclude study participation * No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration * Concurrent low-dose (≤ 325 mg/day) aspirin allowed * At least 3 weeks since other prior therapy for the malignant tumor

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 35 locations

Suspended

Hinsdale Hematology Oncology Associates

Hinsdale, United StatesSee the location
Suspended

CCOP - Carle Cancer Center

Urbana, United States
Suspended

Massachusetts General Hospital Cancer Center

Boston, United States
Suspended

West Michigan Cancer Center

Kalamazoo, United States
Completed35 Study Centers