Colorectal Cancer Clinical Trial
Official title:
Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with
oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent
colon cancer.
OBJECTIVES:
Primary
- Determine the complete response and partial response rates in patients with recurrent
or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the overall and failure-free survival of patients treated with the
chemotherapy regimen.
- Determine the duration of response (complete or partial) in patients treated with this
regimen.
- Determine the percentage of patients who experience a 50% fall of serum
carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving
this regimen.
- Evaluate the toxicity associated with the administration of this regimen in these
patients.
OUTLINE: This is a non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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