Clinical Trial: Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
Brief Summary: This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.
II. To evaluate the value of inhibin for predicting response.
OUTLINE:
Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.
Sponsor: Gynecologic Oncology Group
Current Primary Outcome: Frequency of complete clinical response, assessed using GOG RECIST criteria [ Time Frame: Up to 5 years ]
Original Primary Outcome:
Current Secondary Outcome:
- Duration of progression-free survival [ Time Frame: The period from study entry until disease progression, death or date of last contact, assessed up to 5 years ]
- Overall survival [ Time Frame: The observed length of life from entry into the study to death or the date of last contact, assessed up to 5 years ]
Original Secondary Outcome:
Information By: Gynecologic Oncology Group
Dates:
Date Received: September 11, 2000
Date Started: November 2000
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017
