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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00052585
Enrollment
50
Registered
2003-01-27
Start date
2002-10-31
Completion date
Unknown
Last updated
2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

OBJECTIVES: 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 regimen. 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.

Interventions

DRUGirinotecan hydrochloride

Given IV

DRUGgefitinib

Given orally

DRUGleucovorin calcium

Given IV

DRUGfluorouracil

Given IV

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Grade 3 or 4 toxicity, graded using the NCI CTC version 2.0Up to 2 years
Response rateUp to 2 years95% confidence interval will be determined.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026