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

A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: oxaliplatin

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Study Chair: Milind Javle, MD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): August 1, 2003
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: July 8, 2002
• First Submitted That Met QC Criteria: July 7, 2003
• First Posted (Estimate): July 8, 2003

Study Record Updates

• Last Update Posted (Estimate): March 7, 2011
• Last Update Submitted That Met QC Criteria: March 3, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage III rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: CDR0000069410; RPCI-DS-0130