ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib

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) administered either concurrently (no more than 2 regimens) or sequentially (no more than 3 regimens) for advanced disease

• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• No known brain metastases

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/mm^3

• Platelet count at least 100,000/mm^3

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 gefitinib

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study participation

• No prior gastrointestinal disorders (e.g., malabsorption syndrome)

• No prior allergic reactions attributed to compounds of similar chemical or biological composition to gefitinib

• 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

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