NCT00021268

Brief Summary

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

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

September 10, 2003

Completed
Last Updated

August 2, 2013

Status Verified

October 1, 2002

First QC Date

July 11, 2001

Last Update Submit

August 1, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Interventions

tocladesineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of metastatic carcinoma of the colon or rectum * Recurrent or progressive after failing prior fluorouracil and irinotecan chemotherapy, sequentially or in combination, unless unable to tolerate irinotecan * Measurable disease PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 5 times ULN * PT/aPTT no greater than 1.2 times ULN Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 50 mL/min * No impaired renal function Cardiovascular: * No impaired cardiac function Other: * No active infection * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer * 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 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer drugs * No concurrent chronic non-steroidal anti-inflammatory agents * No concurrent chronic therapeutic anticoagulation

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

8-chloro-cyclic adenosine monophosphate

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lee S. Rosen, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2001

First Posted

September 10, 2003

Study Start

April 1, 2001

Last Updated

August 2, 2013

Record last verified: 2002-10

Locations

US(1)