Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Inclusion Criteria

• Histologically confirmed endometrial carcinoma
• Recurrent or persistent disease
• Histologic confirmation of the original primary tumor is required
• Refractory to curative therapy or standard treatments
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
• Must have at least 1 target lesion
• Tumors within a previously irradiated field are considered non-target lesions
• Disease in an irradiated field as the only site of measurable disease is considered a target lesion provided there has been clear progression of the lesion since the completion of prior radiotherapy
• Must have received 1 prior chemotherapy regimen for endometrial carcinoma
• Initial therapy may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
• No more than 1 additional prior cytotoxic regimen for recurrent or persistent disease
• Tumor accessible to guided core needle or fine needle biopsy
• Ineligible for a higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population)
• Performance status - GOG 0-2 (for patients who have received 1 prior treatment regimen)
• Performance status - GOG 0-1 (for 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)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Cardiac ejection fraction normal by echocardiogram or MUGA
• No gastrointestinal (GI) tract 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 or ulcerative colitis)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No sensory or motor neuropathy > grade 1
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• At least 4 weeks since prior immunologic agents for the malignant tumor
• No prior trastuzumab (Herceptin^®) or any target-specific therapy directed to the HER family (e.g., gefitinib, erlotinib, or cetuximab)
• At least 6 weeks since prior nitrosoureas or mitomycin for the malignant tumor and recovered
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease
• At least 1 week since prior hormonal therapy for the malignant tumor
• Concurrent hormone replacement therapy allowed
• Recovered from prior radiotherapy
• Recovered from prior surgery
• No prior surgery affecting absorption
• At least 4 weeks since other prior therapy for the malignant tumor
• No prior lapatinib
• No prior anticancer treatment that would preclude study treatment
• Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased monitoring of INR
• No concurrent CYP3A4 inducers or inhibitors
• No concurrent combination antiretroviral therapy for HIV-positive patients