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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: pemetrexed disodium

Study type: Interventional

Funder types: NETWORK; Industry; NIH

Identifiers

NCT00087087

GOG-0126Q

CDR0000372919

LILLY-H3E-US-JMGP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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