Trials / Completed
CompletedNCT00313599
Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
A Phase I Dose Escalation Study of a 2 Day Oral Lapatinib Chemosensitization Pulse Given Prior To Weekly Intravenous Abraxane™ in Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 paclitaxel work better by making tumor cells more sensitive to the drug. Lapatinib may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving lapatinib together with paclitaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with paclitaxel in treating patients with advanced solid tumors.
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™) in patients with advanced solid tumor malignancies. Secondary * Define the toxicity of this regimen. * Determine, preliminarily, the antitumor efficacy and safety of ABI-007 when preceded by a 2-day pulse of lapatinib. * Characterize the potential of the molecular markers within circulating tumor cells as markers of response (e.g., HER2 and AKT) or apoptotic markers. * Determine whether lapatinib given at MTD prior to ABI-007 alters the pharmacokinetic properties of the paclitaxel component of ABI-007. OUTLINE: This is a does-escalation study of lapatinib. Patients are stratified according to dose level. Patients receive oral lapatinib on days 1, 2, 8, 9, 15, and 16 and paclitaxel (albumin-stabilized nanoparticle formulation) (ABI-007; Abraxane™) IV over 30 minutes on days 3, 10, and 17. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of lapatinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicities. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Conditions
- Bladder Cancer
- Brain and Central Nervous System Tumors
- Breast Cancer
- Esophageal Cancer
- Extragonadal Germ Cell Tumor
- Gastric Cancer
- Lung Cancer
- Ovarian Cancer
- Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib | |
| DRUG | paclitaxel |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2006-04-12
- Last updated
- 2014-07-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00313599. Inclusion in this directory is not an endorsement.