Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
Bladder Cancer, Brain and Central Nervous System Tumors, Breast Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent breast cancer, stage IV breast cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent prostate cancer, stage IV prostate cancer, recurrent bladder cancer, stage IV bladder cancer, recurrent gastric cancer, stage IV gastric cancer, recurrent esophageal cancer, stage IV esophageal cancer, recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, adult central nervous system germ cell tumor, ovarian choriocarcinoma, ovarian dysgerminoma, ovarian embryonal carcinoma, ovarian yolk sac tumor, ovarian mixed germ cell tumor, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, recurrent extragonadal germ cell tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor, including the following tumor types: Breast cancer Non-small cell lung cancer Prostate cancer Bladder cancer Gastroesophageal junction cancer Ovarian cancer Germ cell tumor Advanced or metastatic disease No effective curative therapy exists Evaluable disease Measurable disease not required Bone-only disease allowed No progressing brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm^3 Bilirubin normal AST/ALT ≤ 2.5 times upper limit of normal Creatinine normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious intercurrent medical or psychiatric illness No serious active infection No gastrointestinal tract disease that would impair a patient's ability to take oral medication No history of significant cardiac disease, including any of the following: Congestive heart failure Symptomatic cardiac arrhythmias Unstable angina No pre-existing peripheral neuropathy ≥ 2 PRIOR CONCURRENT THERAPY: Any number of prior therapies allowed Prior paclitaxel, tyrosine kinase inhibitor therapy, or endothelial growth factor inhibitors allowed At least 14 days since prior and no concurrent CYP3A4 inducers or herbal or dietary supplements At least 7 days since prior and no concurrent CYP3A4 inhibitors At least 6 months since prior and no concurrent amiodarone More than 1 month since prior chemotherapy, radiotherapy, hormonal therapy, or investigational anticancer agents Concurrent continued use of gonadal suppression agents (i.e., goserelin acetate or leuprolide acetate) allowed No antacids 1 hour before and after study drug administration No concurrent retinoids No concurrent hormonal anticancer agent No other concurrent anticancer chemotherapy or investigational anticancer agents
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Lapatinib and Paclitaxel
Lapatinib will be self-administered orally on days 1 and 2 of weeks 1, 2, and 3 of a 4-week cycle. Lapatinib is the experimental therapy and is being administered using a dose escalation design guided by careful monitoring of toxicities. Abraxane will be administered IV weekly on day 3 of weeks 1, 2, and 3 of a 4-week cycle. Abraxane is being administered at the well tolerated and effective standard dose and schedule of 100mg/m2 weekly 3 out of 4 weeks as defined by previous phase I and II studies. Patients will continue on therapy as long as they are not experiencing toxicities and there is no evidence of disease progression.