Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Brief summary
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Detailed description
OBJECTIVES: * Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma. * Determine the nature and degree of toxicity in patients treated with this drug. * Determine the partial and complete response rates in patients treated with this drug. * Determine the duration of progression-free and overall survival in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 1-2 years.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal carcinoma * Recurrent or persistent disease * Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease * Platinum-resistant or refractory * Treatment-free interval of less than 6 months after therapy with platinum-containing regimen OR * Progression during platinum-containing regimen OR * Platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen * At least 1 lesion measurable in at least 1 dimension * At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR * At least 10 mm by spiral CT scan * At least 1 target lesion outside a previously irradiated field * Disease must be accessible to core needle biopsy * Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No unstable cardiac disease * No myocardial infarction within the past 6 months * Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No sensory or motor neuropathy greater than grade 1 * No active corneal disease (e.g., keratoconjunctivitis) * No active infection requiring antibiotics * No evidence of bowel dysfunction that could be related to early bowel obstruction * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior immunological agents for the malignancy * No concurrent anti-cancer immunotherapy Chemotherapy: * See Disease Characteristics * No more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease * No prior noncytotoxic chemotherapy for recurrent or persistent disease * At least 3 weeks since prior chemotherapy for the malignancy and recovered * No concurrent anti-cancer chemotherapy Endocrine therapy: * At least 1 week since prior anticancer hormonal therapy * Concurrent hormone replacement therapy allowed * No concurrent anti-cancer hormonal therapy Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for the malignancy and recovered * No prior radiotherapy to more than 25% of marrow-bearing areas * No concurrent anti-cancer radiotherapy Surgery: * At least 4 weeks since prior surgery (except minor procedures under local anesthesia (e.g., central venous port placement)) and recovered Other: * At least 3 weeks since other prior therapy for the malignancy * No prior gefitinib * No other prior epidermal growth factor receptor inhibitors * No prior anticancer therapy that would preclude study therapy * No concurrent chlorpromazine * No other concurrent investigational agents * No other concurrent antineoplastic agents * No concurrent CYP3A4-inducing agents, including phenytoin, carbamazepine, barbiturates, nafcillin, rifampicin, or St. John's Wort
Countries
Australia, Canada, United Kingdom, United States