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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy  ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
For Condition: stage 4 colon cancer,stage 3 rectal cancer,stage 3 colon cancer,adenocarcinoma of the rectum,Stage 4 rectal cancer,recurrent rectal cancer,recurrent colon cancer,adenocarcinoma of the colon
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Texas
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of colorectal cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to fluorouracil and irinotecan.
Details: OBJECTIVES: I. Determine the progression-free rate at 16 weeks, response rate, time to treatment failure, and survival of patients treated with ZD 1839 for advanced colorectal carcinoma that is refractory to fluorouracil, irinotecan, and capecitabine. II. Correlate the pharmacodynamic effects of this drug with indices of clinical benefit (e.g., tumor growth inhibition, time to tumor progression, and survival) in these patients. III. Determine whether the status of epidermal growth factor receptor (EGFR) activation and signaling are predictive of clinical outcome in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 5-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed colorectal adenocarcinoma - Metastatic or locally advanced disease - Not amenable to curative therapy Documentation of disease progression within the past 6 months Previously treated with fluoropyrimidine- and irinotecan-based chemotherapy including capecitabine either concurrently (no more than 2 regimens for advanced disease) or sequentially (no more than 3 regimens for advanced disease) At least 1 undimensionally measurable lesion - At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No known brain metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: - See Disease Characteristics - At least 30 days since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior gastric resection Other: - No other prior therapy for advanced disease - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents or therapies for the malignancy --Patient Characteristics-- Age: 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% 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/ALT no greater than 3 times ULN (5 times ULN if liver metastasis present) Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 Ml/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Ophthalmic: No significant ophthalmic conditions, including: - Severe dry-eye syndrome - Keratoconjunctivitis sicca - Sjogren's syndrome - Severe-exposure keratopathy - Disorders that may increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) Other: - Able to take oral ZD 1839 - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study - No prior gastrointestinal disorders (e.g., malabsorption syndrome) - No prior allergic reactions attributed to compounds of similar chemical or biological composition to ZD 1839 - No other prior malignancy except carcinoma in situ of the cervix, nonmelanoma skin cancer, or other cancer from which the patient has been free of evident disease for more than 5 years and/or has less than a 20-30% estimated likelihood of recurrence - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChrisTakimoto, Study Chair, University of Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Institute for Drug Development
San Antonio, Texas, 78229
United States
Additional Information:
Study ID Numbers: CDR0000069174; SACI-IDD-01-01,NCI-3753,UTHSC-0015011185
Study Start Date: January 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030524
Other Stage 3 Rectal Cancer Studies:
1. Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
2. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
3. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
4. Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
5. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Related Studies:
Other stage 3 rectal cancer Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
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