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

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

• Must have one of the following:

  • Measurable disease

  • Evaluable disease AND a CA-125 value that has increased ≥ 2 times the nadir value established after debulking surgery and first-line chemotherapy, confirmed by a second measurement within the past 21 days

    • If a second measurement has not been done, it can be done ≥ 7 days but < 21 days prior to study treatment

• Platinum-refractory and/or -resistant disease after first-line chemotherapy

  • Patients retreated with platinum agents (i.e., second relapse) are not eligible
  • 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