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Keep this study
Lead
Roswell Park Cancer Institute
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
