NCT00040820

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

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
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 8, 2003

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

July 8, 2002

Last Update Submit

March 3, 2011

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

oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy * Locally advanced OR * Metastatic disease * Patients who progressed on a non-oxaliplatin-containing (control) arm in Sanofi-Synthelabo second-line regulatory trials OR * Patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens * Documented radiological disease progression after last anticancer treatment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 75,000/mm3 Hepatic: * SGOT or SGPT no greater than 6 times upper limit of normal (ULN) * Bilirubin no greater than 2 mg/dL * Alkaline phosphatase no greater than 5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * Adequate organ function and medically stable * No known concurrent peripheral neuropathy * Absence of deep tendon reflexes as the sole neurologic abnormality is allowed PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 30 days since prior chemotherapy * No prior oxaliplatin-based chemotherapy * No other concurrent investigational chemotherapy agents Endocrine therapy: * Not specified Radiotherapy: * At least 30 days since prior radiotherapy Surgery: * See Disease Characteristics * At least 30 days since prior major surgical procedure or intervention Other: * At least 30 days since other prior anticancer therapy * No other concurrent anticancer agents * No concurrent participation in any other investigational studies

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

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Milind Javle, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2002

First Posted

July 8, 2003

Study Start

January 1, 2002

Primary Completion

August 1, 2003

Study Completion

March 1, 2004

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)