Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin

Exclusion Criteria

• •* Patients treated with first-line triplet therapy (e.g., on clinical trial GOG-182) are eligible
• •Must have had debulking surgery
• •* Tissue blocks from this surgery must be available
• •No CNS metastases
• •PATIENT CHARACTERISTICS:
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• •Life expectancy ≥ 12 weeks
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST ≤ 3 times ULN (5 times ULN if there is liver involvement)
• •Creatinine ≤ 1.5 times ULN
• •Hemoglobin ≥ 9.0 g/dL
• •No uncontrolled infection
• •No New York Heart Association class III or IV heart failure
• •Left Ventricular Ejection Fraction (LVEF) ≥ 50% by echocardiogram
• •No seizure disorder
• •No other prior or concurrent malignancy in the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No prior topotecan hydrochloride
• •More than 4 weeks since prior surgery or procedure involving the peritoneum or pleura
• •* CA125 measurements used as basis for enrollment must be made outside of this 4-week window
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• •More than 4 weeks since prior immunotherapy
• •More than 4 weeks since prior biologic therapy
• •More than 4 weeks since prior radiotherapy
• •No prior radiotherapy to \> 25 % of bone marrow
• •No prior therapy with an anti-epidermal growth factor receptor or anti-HER2 tyrosine kinase inhibitors
• •No prior agents targeting topoisomerase I
• •No prior or concurrent human anti-mouse antibodies (HAMA) in patients with non-measurable disease
• •At least 14 days since prior and no concurrent herbal or dietary supplements
• •* Vitamin supplements are allowed unless they include herbal additives
• •At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
• •* Rifampin
• •* Rifabutin
• •* Rifapentine
• •* Phenytoin
• •* Carbamazepine
• •* Phenobarbital
• •* Efavirenz
• •* Nevirapine
• •* Cortisone (\> 50 mg)
• •* Hydrocortisone (\> 40 mg)
• •* Prednisone (\> 10 mg)
• •* Methylprednisolone (\> 8 mg)
• •* Dexamethasone (\> 1.5 mg)
• •* Oral doses of ≤ 1.6 mg of dexamethasone allowed
• •* Modafinil
• •* Hypericum perforatum (St. John's wort)
• •At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
• •* Clarithromycin
• •* Erythromycin
• •* Troleandomycin
• •* Itraconazole
• •* Ketoconazole
• •* Fluconazole (\> 150 mg daily)
• •* Voriconazole
• •* Delaviridine
• •* Nelfinavir
• •* Amprenavir
• •* Ritonavir
• •* Indinavir
• •* Saquinavir
• •* Lopinavir
• •* Verapamil
• •* Diltiazem
• •* Nefazodone
• •* Fluvoxamine
• •* Cimetidine
• •* Aprepitant
• •* Grapefruit or grapefruit juice
• •At least 6 months since prior and no concurrent amiodarone
• •No concurrent participation in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, gene therapy) for symptom control or therapeutic intent