Clinical trial NCT00436644 (phase 2, status: completed)
Conditions: ovarian cancer, peritoneal cavity cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: lapatinib, topotecan
SMILES: CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
Eligibility criteria:

        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