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


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Milind Javle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069410

NCT ID:

NCT00040820

Start Date:

January 2002

Completion Date:

March 2004

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263