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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the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

Hematopoietic:·

- ANC > 1,500/mm3·

- Platelets > 100,000 mm3·

- Hgb > 8g/dl

Hepatic:·

- Albumin>3gm/dL·

- Total bilirubin < ULN·

- Maximum Alk Phos: >2.5x but < 5x ULN

Renal:·

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

Cardiovascular:·

- 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)

Pulmonary:·

- Not specified


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

· 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.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Daniela Matei, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Institutional Review Board

Study ID:

HOG GYN 03-62

NCT ID:

NCT00216112

Start Date:

December 2003

Completion Date:

July 2007

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Arnett Cancer Care Lafayette, Indiana  47904
Medical & Surgical Specialists, LLC Galesburg, Illinois  61401
Oncology Hematology Associates of SW Indiana Evansville, Indiana  47714
Elkhart Clinic Elkhart, Indiana  46515
Medical Consultants, P.C. Muncie, Indiana  47303
Center for Cancer Care, Inc., P.C. New Albany, Indiana  47150
AP&S Clinic Terre Haute, Indiana  47804
Fort Wayne Oncology & Hematology, Inc Fort Wayne, Indiana  46815