Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Eli Lilly and Company; National Cancer Institute (NCI)
• Treatments: Pemetrexed

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