NCT00003843

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 1998

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 16, 2015

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

November 1, 1999

Last Update Submit

February 13, 2015

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Interventions

irinotecan hydrochlorideDRUG
mutation analysisGENETIC
polymorphism analysisGENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven advanced or disseminated colorectal cancer * Progressive disease on fluorouracil based chemotherapy OR * Recurrence of disease within 12 months of adjuvant therapy with fluorouracil * No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Granulocyte count greater than 1500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT no greater than 3 times ULN (no greater than 5 times ULN if liver involved) Renal: * Creatinine no greater than 2.0 mg/dL * Calcium no greater than 12.0 mg/dL Cardiovascular: * No myocardial infarction within past 6 months * No congestive heart failure requiring therapy Neurologic: * No severe psychiatric disorders * No history of seizures Other: * No active or uncontrolled infection * HIV negative * No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes mellitus (random blood sugar 200 mg/dL or greater) * No other severe concurrent disease * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * Prior oxaliplatin allowed * No prior irinotecan or topotecan Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

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

Sponsors & Collaborators

Study Sites (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

IrinotecanAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Heinz-Josef Lenz, MD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1998

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

February 16, 2015

Record last verified: 2013-09

Locations

US(3)