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A Phase II Trial Of IRESSA (NSC 715055, IND 61187) In Combination With 5-FU/LV/ CPT-11 In Patients With Advanced Or Recurrent Colorectal Cancer

Phase 2
18 Years
Not Enrolling
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

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Trial Information

A Phase II Trial Of IRESSA (NSC 715055, IND 61187) In Combination With 5-FU/LV/ CPT-11 In Patients With Advanced Or Recurrent Colorectal Cancer


I. Determine the safety of gefitinib, fluorouracil, leucovorin calcium, and irinotecan in
patients with advanced or recurrent colorectal cancer.

II. Determine the major side effects of this regimen in these patients. III. Determine the
response rate, progression-free survival, and overall survival of patients treated with this

IV. Correlate response and other measures of outcome with epidermal growth factor receptor
expression and the expression of genes that impact upon pathways of fluoropyrimidine
cytotoxicity in patients treated with this regimen.

OUTLINE: This is a non-randomized, open-label, multi-center study.

Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on
days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds
followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- 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

- More than 4 weeks since prior radiotherapy and recovered

- At least 6 months since prior adjuvant therapy

- No prior epidermal growth factor receptor inhibitor

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, rifapentine,
oxacarbazepine, modafinil, griseofulvin, or Hypericum perforatum

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 3 or 4 toxicity, graded using the NCI CTC version 2.0

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Peter O'Dwyer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Colorectal Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283