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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045201 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with irinotecan in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: erlotinib hydrochloride Drug: irinotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of OSI-774 and CPT-11 in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 92 |
Study Start Date: | August 2002 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to UGTA1A genotype (all patients regardless of genotype [closed to accrual as of 9/15/04] vs UGT1A1 6/6 genotype vs UGTA1A 6/7 or 7/7 genotype).
Patients receive oral erlotinib daily on days -6 to -1. Patients then receive irinotecan IV over 90 minutes on day 1 and oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients per stratum receive escalating doses of erlotinib and irinotecan 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. Additional patients are treated at the MTD.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 92 patients (20 in stratum 1 [closed to accrual as of 9/15/04], 42 in stratum 2, and 30 in stratum 3) will be accrued for this study within 3.25-5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Ophthalmic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Henry C. Pitot, MD | Mayo Clinic |
Study ID Numbers: | CDR0000256910, MAYO-MC0112, NCI-5351 |
Study First Received: | September 6, 2002 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00045201 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Erlotinib Irinotecan Camptothecin |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |