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Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00040820
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : March 7, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Colorectal Cancer Drug: oxaliplatin

Detailed Description:


  • Provide oxaliplatin for patients with previously treated locally advanced or metastatic colorectal cancer who have exhausted all approved therapies for colorectal cancer.

OUTLINE: This is a multicenter, Treatment Access Program study.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 30 days.

PROJECTED ACCRUAL: Approximately one patient per site per month will be accrued for this study.

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients
Study Start Date : January 2002
Primary Completion Date : August 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 75,000/mm3


  • 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


  • Creatinine no greater than 1.5 times ULN


  • 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


Biologic therapy:

  • Not specified


  • 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


  • At least 30 days since prior radiotherapy


  • See Disease Characteristics
  • At least 30 days since prior major surgical procedure or intervention


  • At least 30 days since other prior anticancer therapy
  • No other concurrent anticancer agents
  • No concurrent participation in any other investigational studies
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040820

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Study Chair: Milind Javle, MD Roswell Park Cancer Institute
More Information

Responsible Party: Miland Javle, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00040820     History of Changes
Other Study ID Numbers: CDR0000069410
First Posted: July 8, 2003    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by Roswell Park Cancer Institute:
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents