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

NCT ID: NCT00040820

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2004-03-31

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.

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Milind Javle, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-DS-0130

Identifier Type: -

Identifier Source: secondary_id

CDR0000069410

Identifier Type: -

Identifier Source: org_study_id