Clinical Trials Directory

Trials / Completed

CompletedNCT00005837

Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent or refractory cervical cancer.

Detailed description

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory squamous cell carcinoma of the cervix who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population. OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.

Conditions

Interventions

TypeNameDescription
DRUGoxaliplatin

Timeline

Start date
2000-02-01
Completion
2004-06-01
First posted
2003-05-05
Last updated
2013-06-21

Locations

72 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00005837. Inclusion in this directory is not an endorsement.