Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00323063
First received: May 8, 2006
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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
Breast Cancer
Drug: gemcitabine hydrochloride
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (complete and partial response) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive gemcitabine hydrochloride IV on days 3 and 10.
Drug: gemcitabine hydrochloride
Given IV
Experimental: Arm II
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
Drug: gemcitabine hydrochloride
Given IV
Drug: imatinib mesylate
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Compare time to progression in patients with previously treated locally advanced or metastatic breast cancer treated with gemcitabine hydrochloride with vs without imatinib mesylate.

Secondary

  • Compare the efficacy of these regimens in these patients.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the safety and tolerability of these regimens in these patients.

OUTLINE: This is a multicenter, open-label, randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
  • Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Locally advanced or metastatic disease
    • Disease progression after at least 1 prior chemotherapy regimen for metastatic disease

      • No more than 2 prior chemotherapy regimens for metastatic disease (prior neoadjuvant or adjuvant treatment will not be included in determining the number of prior chemotherapy regimens)
  • Measurable disease
  • No known symptomatic or untreated brain metastases or carcinomatous meningitis

    • Previously treated and clinically stable brain metastases allowed provided patient has been off steroids for > 7 days
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy
  • Able to swallow oral medication
  • No coexisting medical condition that would preclude study compliance
  • No uncontrolled illness, including any of the following:

    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia requiring therapy
    • Myocardial infarction within the past 6 months
    • Active infection
  • No New York Heart Association class III-IV cardiac disease
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine hydrochloride and/or imatinib mesylate
  • No other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
  • No known HIV infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • More than 2 weeks since prior surgery
  • At least 2 weeks since prior hormonal therapy
  • At least 2 weeks since prior trastuzumab (Herceptin®)
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 3 weeks since prior anti-vascular endothelial growth factor therapy
  • More than 28 days since prior investigational agents
  • At least 3 weeks since prior radiotherapy

    • Must have evidence of ≥ 1 measurable target lesion outside the irradiated fields OR radiologically confirmed disease progression within the irradiated fields after completion of radiotherapy
  • No prior imatinib mesylate for metastatic disease
  • No prior gemcitabine hydrochloride for metastatic disease
  • More than 6 months since prior adjuvant gemcitabine hydrochloride
  • No other concurrent investigational or commercial agents
  • No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or Coumadine®)

    • Concurrent heparin or low-molecular weight heparin (e.g., Lovenox®) for therapeutic anticoagulation allowed
    • Concurrent prophylactic warfarin therapy (e.g., mini-dose Coumadin® ≤ 1 mg daily) to maintain catheter patency allowed
  • No concurrent routine chronic systemic corticosteroids
  • No concurrent medications that would preclude study compliance
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323063

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Mountainside Hospital
Montclair, New Jersey, United States, 07042
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Novartis Pharmaceuticals
Investigators
Principal Investigator: Antoinette R. Tan, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00323063     History of Changes
Other Study ID Numbers: 040504, P30CA072720, CDR0000539445, 0220060081, NJ1105
Study First Received: May 8, 2006
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
recurrent breast cancer
stage IV breast cancer
male breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Imatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014