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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Recurrent Metastatic Colorectal Cancer  ZD 1839 in Treating Patients With Recurrent Metastatic Colorectal Cancer
ZD 1839 in Treating Patients With Recurrent Metastatic Colorectal Cancer
For Condition: recurrent rectal cancer,stage 4 colon cancer,recurrent colon cancer,adenocarcinoma of the rectum,Stage 4 rectal cancer,adenocarcinoma of the colon
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of recurrent metastatic colorectal cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of ZD 1839 in treating patients who have recurrent metastatic colorectal cancer.
Details: OBJECTIVES: I. Determine the 4-month progression-free survival rate in patients with recurrent metastatic colorectal adenocarcinoma treated with ZD 1839. II. Determine the objective tumor response rate, progression, and overall survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified according to ECOG performance status (0-1 vs 2), baseline serum CEA (less than 5 mg/L vs at least 5 mg/L), and number of metastatic sites (1 vs 2 or more). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral ZD 1839 once daily (twice daily on day 1 of course 1). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive a higher dose of oral ZD 1839 as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven adenocarcinoma of the colon or rectum - Measurable disease - Radiographic evidence of progressive metastatic disease within 6 months after treatment with prior irinotecan, fluorouracil, and leucovorin calcium; Prior therapy may have been administered concurrently or sequentially; Prior adjuvant therapy for locally advanced colorectal cancer (i.e., stage II or III or Dukes stage B or C) allowed provided there is evidence of metastatic disease and progression - Metastatic tumor site accessible for biopsy - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior epidermal growth factor receptor-inhibiting agents - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered - Surgery: Not specified - Other: No other concurrent investigational agents; No concurrent antiretroviral therapy for HIV-positive patients --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: More than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the liver) - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min - Cardiovascular: No New York Heart Association class III or IV heart disease; No symptomatic congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No ongoing active or uncontrolled infections; Other prior malignancies allowed provided prior therapy is discontinued and no evidence of disease; No other uncontrolled illness or psychiatric illness/social situations that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaceRothenberg, Study Chair, Eastern Cooperative Oncology Group
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000068952; E-6200
Study Start Date: October 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025350
Other Recurrent Rectal Cancer Studies:
1. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
2. Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
3. Capecitabine in Treating Older Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
4. Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
5. Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver
Related Studies:
Other recurrent rectal cancer Clinical Trials
Other North Dakota Clinical Trials
Other Fargo Clinical Trials
ZD 1839 in Treating Patients With Recurrent Metastatic Colorectal Cancer
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