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| Sponsor: | Institute for Drug Development |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00042809 |
Purpose
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with paclitaxel in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: trastuzumab Drug: erlotinib hydrochloride Drug: paclitaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Combined EGFR (erbB1) And HER2 (erbB2) Blockade, With OSI-774 And Trastuzumab, In Combination With Weekly Paclitaxel |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2002 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of erlotinib.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 30 days.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 10-13.3 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No evidence of leptomeningeal disease or brain metastases unless previously treated, currently asymptomatic, and off both antiepileptics and dexamethasone
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Texas | |
| Cancer Therapy and Research Center | |
| San Antonio, Texas, United States, 78229 | |
| San Antonio Cancer Institute | |
| San Antonio, Texas, United States, 78229-3264 | |
| Study Chair: | Anthony W. Tolcher, MD | Cancer Therapy and Research Center, Texas |
More Information
| ClinicalTrials.gov Identifier: | NCT00042809 History of Changes |
| Other Study ID Numbers: | CDR0000069472, CTRC-IDD-0135, NCI-5439 |
| Study First Received: | August 5, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms Paclitaxel Trastuzumab Erlotinib Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |