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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00323063 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared to gemcitabine alone in treating patients with previously treated locally advanced or metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: gemcitabine hydrochloride Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive gemcitabine hydrochloride IV on days 3 and 10.
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Drug: gemcitabine hydrochloride
Given IV
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Arm II: Experimental
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
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Drug: gemcitabine hydrochloride
Given IV
Drug: imatinib mesylate
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, randomized study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Disease progression after at least 1 prior chemotherapy regimen for metastatic disease
No known symptomatic or untreated brain metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
No uncontrolled illness, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior radiotherapy
No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or Coumadine®)
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Principal Investigator: | Antoinette R. Tan, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000539445, CINJ-040504, CINJ-0220060081, CINJ-NJ1105 |
Study First Received: | May 8, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00323063 |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer male breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Imatinib Skin Diseases Breast Neoplasms, Male Breast Neoplasms |
Gemcitabine Breast Diseases Recurrence |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |