Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer
Recurrent Endometrial Carcinoma
About this trial
This is an interventional treatment trial for Recurrent Endometrial Carcinoma
Eligibility Criteria
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
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.