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A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma


- Determine the 4-month progression-free survival rate in patients with recurrent
metastatic colorectal adenocarcinoma treated with gefitinib.

- Determine the objective tumor response rate, progression, and overall survival of
patients treated with this drug.

- Determine the toxicity of this drug in these patients.

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 1 of 2 treatment

- Arm I: Patients receive oral gefitinib once daily (twice daily on day 1 of course 1).
Courses repeat every 28 days in the absence of disease progression or unacceptable

- Arm II: Patients receive a higher dose of oral gefitinib as in arm I. Patients are
followed every 3 months for 2 years, every 6 months for 3 years, and then annually

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this

Inclusion Criteria


- Histologically or cytologically proven adenocarcinoma of the colon or rectum

- Measurable disease

- Evidence of new or progressive metastatic disease within 6 months of last treatment

- Must have received prior systemic treatment with fluorouracil (and/or its analogs,
with or without leucovorin calcium or levamisole) and irinotecan in the adjuvant or
metastatic setting

- Metastatic tumor site accessible for biopsy

- No known brain metastases



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 12 weeks


- Absolute neutrophil 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 or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the


- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 60 mL/min


- No New York Heart Association class III or IV heart disease

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- Not pregnant or nursing

- Negative pregnancy test

- 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

- Must be able to take and retain oral medications


Biologic therapy:

- No prior signal transduction inhibitors (e.g., vascular endothelial growth factor-,
vascular endothelial growth factor receptor-, and epidermal growth factor
receptor-targeted agents) for colorectal cancer


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy and recovered

- No other prior cytotoxic chemotherapy (e.g., oxaliplatin) for colorectal cancer

Endocrine therapy:

- Not specified


- At least 4 weeks since prior radiotherapy and recovered


- Not specified


- No other prior systemic therapy for colorectal cancer

- No other prior investigational or approved agents for colorectal cancer

- No other concurrent investigational agents

- No concurrent antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Mace L. Rothenberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

June 2006

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Adenocarcinoma
  • Colorectal Neoplasms



Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Merit Care Hospital Fargo, North Dakota  58122
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
CCOP - Evanston Evanston, Illinois  60201
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Veterans Affairs Medical Center - New York New York, New York  10010
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212