NCT00928642

Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer

A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.

Detailed description

Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	imatinib mesylate by mouth	imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.
DRUG	Gemcitabine Intravenous	Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-06-26
• Last updated: 2014-10-21
• Results posted: 2014-10-21

Locations

1 site across 1 country: United States