Imatinib Mesylate in Combination With Docetaxel for Advanced, Platinum-Refractory Ovarian Cancer

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

Imatinib mesylate is an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. Docetaxel promotes cell growth arrest by inhibiting the deassembly of tubulin and by promoting at the same time microtubule assembly. Docetaxel has single agent activity in ovarian cancer with response rates of 30-40% in the platinum refractory setting. The combination of imatinib mesylate and docetaxel has potential synergistic effects, based on previous reports showing synergy in-vitro and in-vivo between PDGFR inhibitors or PI3K inhibitors and taxane chemotherapy. This trial will investigate the efficacy the combination of imatinib mesylate and docetaxel in treating patients with advanced, platinum-refractory ovarian cancer and primary peritoneal carcinomatosis.

Key facts

Study ID

NCT00216112

Run by

Daniela Matei, MD

People needed

23

Starts

2003-12-01

Expected to finish

2007-07-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented diagnosis of ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer·
• Immunohistochemical documentation of c-Kit or PDGFR expression by tumor
• At least one measurable site of disease as defined by RECIST or evidence of disease progression by CA125 measurement
• Platinum-refractory or platinum-resistant

You may not qualify if…

• No prior exposure to imatinib (Gleevec®) as single agent or in combination
• No chemotherapy within 28 days (42 days for nitrosourea or mitomycin-C) prior to being registered to protocol therapy.
• No prior radiotherapy to ³ 25 % of the bone marrow
• No known brain metastases.
• Negative pregnancy test
• No current breastfeeding
• No investigational agents within 28 days prior to protocol therapy
• No prior malignancy in the past 5 years unless the other primary malignancy is not currently clinically significant, nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
• No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
• No known diagnosis of human immunodeficiency virus (HIV) infection.
• No major surgery within 28 days prior to being registered to protocol therapy.
• No refractory ascites requiring drainage more frequently than once a month
• No presence of clinically significant small bowel obstruction
• No prior exposure to docetaxel (exposure to paclitaxel is allowed)
• No parenteral nutrition within 28 days prior to being registered to protocol therapy.
• No concomitant treatment with potent CYP 3A4 inhibitors (i.e., ketoconazole) is permitted during therapy on this protocol.
• No therapeutic anticoagulation with warfarin while on study (use of low molecular weight heparin is allowed, if necessary).
• No peripheral neuropathy > grade 1
• No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
• No serious concomitant systemic disorders incompatible with the study
• No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin, carcinoma in-situ of the cervix, or any other cancer for which the patient has been disease-free for < 5 years.

Where it is running

• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Arnett Cancer Care — Lafayette, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Center for Cancer Care, Inc., P.C. — New Albany, Indiana, United States
• AP&S Clinic — Terre Haute, Indiana, United States

Full record on ClinicalTrials.gov

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