Status:
COMPLETED
Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may help p...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of a 2-day pulse of lapatinib that can be given prior to paclitaxel (albumin-stabilized nanoparticle formulation ) (ABI-007; Abraxane...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00313599
Start Date
February 1 2006
End Date
December 1 2013
Last Update
July 2 2014
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115