Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

Inclusion Criteria

• Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal cancer
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Presence of ≥ 1 target lesion
• Tumors within a previously irradiated field are not considered target lesions unless evidence of progression is documented or proven by biopsy 3 months after completion of radiotherapy
• Disease progression during OR persistent disease after 1 prior platinum-based chemotherapy regimen* for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
• Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
• Treatment-free interval after platinum-based chemotherapy grade 1
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib
• At least 4 weeks since prior immunologic agents for the malignancy
• No prior trastuzumab (Herceptin®)or cetuximab
• See Disease Characteristics
• Recovered from prior chemotherapy
• At least 6 weeks since prior nitrosoureas or mitomycin for the malignancy
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease
• At least 2 weeks since prior and no concurrent dexamethasone or dexamethasone equivalent dose > 1.5 mg/day
• At least 1 week since prior hormonal therapy for the malignancy
• Concurrent hormone replacement therapy allowed
• See Disease Characteristics
• Recovered from prior radiotherapy
• No prior radiotherapy to > 25% of marrow-bearing areas
• See Disease Characteristics
• Recovered from prior surgery
• No prior surgical procedure affecting gastrointestinal (GI) absorption
• At least 4 weeks since other prior therapy for the malignancy
• At least 6 months since prior and no concurrent amiodarone
• At least 1 week since other prior and no concurrent CYP3A4 inhibitors
• At least 2 weeks since prior and no concurrent CYP3A4 inducers
• At least 1 week since prior and no concurrent H2 inhibitors or proton pump inhibitors
• Concurrent antacids allowed provided they are not administered within 1 hour before and 1 hour after study drug administration
• No prior cancer treatment that would preclude study treatment
• No prior lapatinib
• No other prior target-specific therapy directed to the HER family (e.g., gefitinib or erlotinib)
• No concurrent herbal medications
• No concurrent combination antiretroviral therapy for HIV-positive patients