NCT00030524

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of colorectal cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

February 14, 2002

Last Update Submit

October 26, 2012

Conditions

Colorectal Cancer

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

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

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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 1, 2002

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

US(2)