A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients
18 Years
N/A
Both
Colorectal Cancer
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 Institute | Buffalo, New York 14263 |
