Conditions: Ovarian Cancer Primary Peritoneal Cancer
Keywords: ovarian cancer peritoneal endometrioid mucinous serous clear cell
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief 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progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.

Arms:
arm 1: 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.

Interventions: intervention 1: imatinib mesylate by mouth intervention 2: Gemcitabine Intravenous
Intervention descriptions: intervention 1: imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle. intervention 2: Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle

Protocol document: