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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00216112
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 19, 2016
Novartis Pharmaceuticals
Walther Cancer Institute
Information provided by (Responsible Party):
Daniela Matei, MD, Hoosier Cancer Research Network

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Imatinib Mesylate Drug: Docetaxel Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

Submit tumor and serum samples for central review

  • Imatinib 600 mg (orally qd);
  • Docetaxel 30mg/m2 (4 of 6 weeks);1 cycle = 6 weeks
  • Evaluate every other cycle

Each cycle will begin only when the granulocyte count is > 1,500/mm3 and the platelet count is > 100,000/mm3 and any other treatment-related toxicities are < grade 1. If the toxicity is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the study. For days 8, 15, and 22 patients must have an absolute neutrophil count > 1,000/mm3 or greater and platelet count > 75,000/mm3. Imatinib mesylate can be administered if platelets >20,000 and ANC >500.

ECOG performance status 0 or 1


  • ANC > 1,500/mm3·
  • Platelets > 100,000 mm3·
  • Hgb > 8g/dl


  • Albumin>3gm/dL·
  • Total bilirubin < ULN·
  • Maximum Alk Phos: >2.5x but < 5x ULN


  • Creatinine < 1.5 x ULN·(by Cockroft and Gault)


  • No grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months prior to beginning protocol therapy)


  • Not specified

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imatinib Mesylate (Gleevec®, STI571) in Combination With Docetaxel (Taxotere) for the Treatment of Advanced, Platinum-Refractory Ovarian Cancer and Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN03-62
Study Start Date : December 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : July 2007

Arm Intervention/treatment
Experimental: Investigational Treatment
Imatinib Mesylate + Docetaxel
Drug: Imatinib Mesylate
Imatinib mesylate 600 mg po qd

Drug: Docetaxel
Docetaxel 30 mg/m2 (4 of 6 weeks); 1 cycle = 6 weeks

Primary Outcome Measures :
  1. · To determine response rate (CR, PR and SD) of patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit receiving imatinib mesylate in combination with docetaxel. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. · To assess the safety and tolerability of imatinib mesylate in combination with docetaxel in patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit. [ Time Frame: 24 months ]
  2. · To determine progression free survival and overall survival in patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit, receiving imatinib mesylate in combination with docetaxel. [ Time Frame: 24 months ]
  3. · To determine whether basal level of Akt expression or Akt activation (phospho-Akt) in ovarian tumors impacts response to treatment with imatinib and docetaxel. [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00216112

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United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States, 47150
AP&S Clinic
Terre Haute, Indiana, United States, 47804
Sponsors and Collaborators
Daniela Matei, MD
Novartis Pharmaceuticals
Walther Cancer Institute
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Study Chair: Daniela Matei, M.D. Hoosier Oncology Group, LLC
Additional Information:
Publications of Results:
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Responsible Party: Daniela Matei, MD, Sponsor-Investigator, Hoosier Cancer Research Network Identifier: NCT00216112    
Other Study ID Numbers: HOG GYN 03-62
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniela Matei, MD, Hoosier Cancer Research Network:
Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Imatinib Mesylate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors