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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026299 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy with gefitinib may kill more tumor cells.
PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without gefitinib in treating patients who have metastatic or locally recurrent colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: gefitinib Drug: oxaliplatin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma |
| Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of gefitinib followed by a phase II randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2).
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Phase II: Patients are randomized to one of two treatment arms.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive gefitinib alone until disease progression.
PROJECTED ACCRUAL: Approximately 77 patients (9 for phase I and 68 for phase II) will be accrued for this study within 12-14 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5589 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| United States, Michigan | |
| Oncology Care Associates, P.L.L.C. | |
| Saint Joseph, Michigan, United States, 49085 | |
| Study Chair: | Hedy L. Kindler, MD | University of Chicago |
More Information
| ClinicalTrials.gov Identifier: | NCT00026299 History of Changes |
| Other Study ID Numbers: | CDR0000069016, UCCRC-11089, NCI-3857 |
| Study First Received: | November 9, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Oxaliplatin Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |