Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer

Stopped early · Phase 2

Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

Phase II trial to study the effectiveness of combining gefitinib with fluorouracil, leucovorin, and irinotecan in treating patients who have advanced or recurrent colorectal cancer. Biological therapies such as gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with fluorouracil, leucovorin, and irinotecan may kill more tumor cells

Key facts

Study ID

NCT00052585

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2002-10-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed advanced (stage IV) or recurrent adenocarcinoma of the colon or rectum
• Must have available tissue for immunohistochemical analysis
• At least one unidimensionally measurable lesion
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Tumor marker (carcinoembryonic antigen) elevation alone is insufficient for study entry
• No known brain metastases
• Performance status - ECOG 0-2
• Granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST less than 2 times ULN (5 times ULN if liver involvement of tumor)
• Creatinine no greater than 1.5 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No other severe or uncontrolled concurrent illness that would adversely impact the safety or efficacy of study therapy
• No ongoing or active infection
• No other prior malignancy unless curatively treated and no evidence of recurrence
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib
• No psychiatric illness or social situation that would preclude study compliance
• No prior chemotherapy for advanced disease
• More than 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Where it is running

• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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