Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer

Phase 2

Terminated

• Conditions: Cervical Cancer; Ovarian Cancer

• Registration Number: NCT00002478
• Lead Sponsor: Gynecologic Oncology Group

Brief 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 etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.

Detailed Description

OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.

OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.

Study Timeline

• Study Start: 1993-06
• Study First Submitted: 1999-11-01
• Status Verified: 2000-11
• Primary Completion: 2003-10
• Study First Submitted QC: 2004-06-08
• Study First Posted: 2004-06-09
• Last Update Submitted: 2013-06-07
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (47)

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Emory University Hospital - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Scroll for more (37 remaining)