Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
Part of paid clinical trials in San Antonio, Texas.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00042809
- Phase
- PHASE1
- Status
- Completed
Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- paclitaxel — DRUGGiven IV
- trastuzumab — BIOLOGICALGiven IV
- erlotinib hydrochloride — DRUGGiven orally
- laboratory biomarker analysis — OTHERCorrelative studies
- pharmacological study — OTHERCorrelative studies
Study Details
Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with paclitaxel in treating patients who have advanced solid tumors. Biological therapies such as erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells
Key Dates
- First listed
- Jan 27, 2003
- Start date
- May 31, 2002
- Status verified
- Jan 2013
- Primary completion
- Dec 31, 2007
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)See detailed description.
Primary Outcome Measure
Maximally tolerated dose (MTD), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to day 28 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cancer Therapy and Research Center at The UT Health Science Center at San Antonio | San Antonio | Texas | 78229 | - |
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