Who is sponsoring NCT00928642?

NCT00928642 is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.

What condition does NCT00928642 study?

NCT00928642 studies Ovarian Cancer, Primary Peritoneal Cancer.

What drugs are being tested in NCT00928642?

Interventions: imatinib mesylate by mouth, Gemcitabine Intravenous.

What is the status of NCT00928642?

NCT00928642 is currently COMPLETED.

Last reviewed 2014-10-20 · How we verify

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

NCT00928642 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Henry M. Jackson Foundation for the Advancement of Military Medicine
Phase	Phase 2
Status	COMPLETED
Enrolment	8
Start date	2009-06
Completion	2010-11

Conditions

Ovarian Cancer
Primary Peritoneal Cancer

Interventions

imatinib mesylate by mouth
Gemcitabine Intravenous

Primary outcomes

The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma. — Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.
Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as \> 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.
To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria — Until disease progression or unacceptable toxicity
Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria

Countries

United States