Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
Eligibility Criteria
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 < 12 months Tumor accessible by guided core needle or fine needle biopsy Ineligible for any higher priority Gynecologic Oncology Group (GOG) protocols (i.e., any active phase III protocol for the same patient population) Performance status - GOG 0-2 (patients who have received 1 prior treatment regimen) Performance status - GOG 0-1 (patients who have received 2 prior treatment regimens) Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN Ejection fraction normal by echocardiogram or MUGA No GI disease resulting in an inability to take oral medication No malabsorption syndrome No requirement for IV alimentation No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment No active infection requiring antibiotics No sensory or motor neuropathy > 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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.