Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045188
First received: September 6, 2002
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth


Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of STI571 in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response (CR + PR), as determined by the RECIST criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Reported using the Kaplan-Meier method with 95% confidence intervals indicated.

  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Reported using the Kaplan-Meier method with 95% confidence intervals indicated.


Enrollment: 35
Study Start Date: August 2002
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
Drug: imatinib mesylate
Given PO
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Optional correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the efficacy of STI571 in metastatic breast cancer (MBC) that demonstrates expression of CD117 (c-kit) and/ or PDGFR.

SECONDARY OBJECTIVES:

I. To determine the clinical activity of STI571 in MBC with expression of CD117 (ckit) and/ or PDGFR by evaluating progression-free survival (PFS).

II. To determine the toxicity profile and tolerability of STI571 in patients with MBC.

III. To define serum, tissue and imaging surrogate endpoints of activity of STI571 in MBC.

OUTLINE:

Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast cancer
  • Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor

    • Adequate tumor tissue from either the primary tumor and/or metastatic disease available for evaluation
  • Must have received prior chemotherapy with an anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Bone disease may not be only source of measurable disease
    • Pleural or peritoneal ascites are not considered measurable disease
  • No known brain metastases
  • Hormone receptor status:

    • Not specified
  • Female or male
  • Not specified
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 12 weeks
  • Absolute neutrophil count at least 1,500/mm^3
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin normal
  • AST or ALT no greater than 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No prior allergic reaction attributed to compounds of similar chemical or biologic composition to imatinib mesylate
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 1 week after study
  • No concurrent biologic agents
  • No more than 2 prior chemotherapy regimens for metastatic disease

    • Therapy with high-dose regimens or bone marrow transplantation considered 1 regimen
  • At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered
  • No concurrent chemotherapy
  • Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior localized radiotherapy that does not influence the signal of the evaluable lesion is allowed
  • At least 2 weeks since prior minor surgery
  • At least 4 weeks since prior major surgery
  • Recovered from prior surgery
  • Low-molecular weight heparin or heparin allowed for anticoagulation
  • No concurrent warfarin
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent investigational therapies or agents
  • No other concurrent anticancer therapy
  • No concurrent intake of cola, orange juice, grapefruit, or orange or grapefruit sections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045188

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Massimo Cristofanilli M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045188     History of Changes
Other Study ID Numbers: NCI-2012-02491, IDO1-691, N01CM17003, CDR0000256915
Study First Received: September 6, 2002
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014