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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049101 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin, leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: erlotinib hydrochloride Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study Of OSI-774 In Combination With Oxaliplatin, And 5-Fluourouracil In Patients With Metastatic Colorectal Carcinoma |
| Study Start Date: | August 2002 |
OBJECTIVES:
OUTLINE: This is a 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 for at least 6 months or until disease progression.
PROJECTED ACCRUAL: A total of 4-18 patients will be accrued for phase I of this study within 1-4 months. A total of 50 patients will be accrued for phase II of this study within 10 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colon or rectal cancer
Unidimensionally measurable disease required for phase II only
The following are not considered measurable:
Recurrent disease after surgery or radiotherapy is considered measurable as long as the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Opthalmic
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Phase I:
Phase II:
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00049101 History of Changes |
| Other Study ID Numbers: | CDR0000257808, MSKCC-02039, NCI-5371 |
| Study First Received: | November 12, 2002 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin |
Erlotinib Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |