Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
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.
Primary Peritoneal Cancer
Drug: imatinib mesylate by mouth
Drug: Gemcitabine Intravenous
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies|
- 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 Frame: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years. ] [ Designated as safety issue: Yes ]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 [ Time Frame: Until disease progression or unacceptable toxicity ] [ Designated as safety issue: Yes ]Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria
- Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment. [ Time Frame: Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified ] [ Designated as safety issue: No ]
Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as "complete response", "partial response", "stable disease", and "progressive disease" after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.
the measurement reported is the number of patients who met the criteria for partial response.
- To Determine the Distribution of the Overall Survival [ Time Frame: Until death ] [ Designated as safety issue: No ]All subjects were followed after treatment was complete to assess overall survival.
- To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial) [ Time Frame: until disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]
Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.
Repsonse rate was the sum of Complete Repsonse and Partial Response.
- To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall. [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.
|Study Start Date:||June 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Oral Imatinib plus intravenous gemcitabine
All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle.
All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. .
All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy.
Drug: imatinib mesylate by mouth
imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.
Other Name: GleevecDrug: Gemcitabine Intravenous
Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle
Other Name: Gemzar
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928642
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||David McCune, MD, MPH||Madigan Army Medical Center|