Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine the objective response rates for the combination of paclitaxel and oxaliplatin in patients with metastatic or locally recurrent cervical cancer. II. To determine the toxicities and recovery from toxicities of patients with cervical cancer receiving paclitaxel and oxaliplatin. OUTLINE: Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed ever 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Given IV
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Overall Objective Response Rate (CR+PR)
95% confidence interval will be estimated via binomial proportions.
Time frame: Up to 7 years
Progression-free Survival
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time frame: From first treatment day until objective or symptomatic progression or death, assessed up to 7 years
Overall Survival
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time frame: From first treatment day until death, assessed up to 7 years
Toxicities, Assessed and Graded According to CTCAE Version 3.0
Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities
Time frame: Up to 7 years
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