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 — DRUG
    Given IV
  • trastuzumab — BIOLOGICAL
    Given IV
  • erlotinib hydrochloride — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative 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)

FacilityCityStateZIPSite coordinators
Cancer Therapy and Research Center at The UT Health Science Center at San AntonioSan AntonioTexas78229-

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