Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

stage III colon cancerstage IV colon cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Interventions

gefitinibDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

The University of Texas Health Science Center at San Antonio
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (2)

Institute for Drug Development

San Antonio, Texas, 78229, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

Chris H. Takimoto, MD, PhD
The University of Texas Health Science Center at San Antonio
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Masking: NONE
Purpose: TREATMENT
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

May 7, 2003

Study Start

January 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2003

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations