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

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00040820
First received: July 8, 2002
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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 Intervention
Colorectal Cancer
Drug: oxaliplatin

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: January 2002
Study Completion Date: March 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040820

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

Additional Information:
No publications provided

Responsible Party: Miland Javle, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00040820     History of Changes
Other Study ID Numbers: CDR0000069410, RPCI-DS-0130
Study First Received: July 8, 2002
Last Updated: March 3, 2011
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014