A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma
OBJECTIVES:
- Determine the recommended phase II dose of gefitinib when administered in combination
with oxaliplatin in patients with metastatic or locally recurrent colorectal cancer.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Compare the time to progression, objective response rate, and median and overall
survival in patients treated with oxaliplatin with or without gefitinib.
- Compare the toxicity of these regimens in these patients.
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).
- Phase I: Patients receive oxaliplatin IV over 2 hours on day 1 and oral gefitinib once
daily on days 1-21. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
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.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive oxaliplatin as in arm I and oral gefitinib once daily at
the MTD on days 1-21.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended dose of ZD1839 in combination with oxaliplatin
3 weeks
Yes
Hedy L. Kindler, MD
Study Chair
University of Chicago
United States: Federal Government
11089A
NCT00026299
September 2001
February 2005
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Oncology Care Associates, P.L.L.C. | Saint Joseph, Michigan 49085 |
LaGrange Memorial Hospital | LaGrange, Illinois 60525 |