Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer
Condition: Recurrent Endometrial Carcinoma
MeSH terms: Carcinoma; Endometrial Neoplasms; Recurrence
Intervention: lapatinib ditosylate
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well lapatinib works in treating patients with recurrent
      or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking
      the enzymes necessary for their growth
    

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