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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00040820

CDR0000069410

RPCI-DS-0130

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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