- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045188
Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
Phase II Trial of STI571 in Metastatic Breast Cancer
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Optional correlative studies
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective tumor response (CR + PR), as determined by the RECIST criteria
Time Frame: Up to 2 years
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Time to progression
Time Frame: Up to 2 years
|
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
|
Up to 2 years
|
Overall survival
Time Frame: Up to 2 years
|
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Massimo Cristofanilli, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02491
- N01CM17003 (U.S. NIH Grant/Contract)
- IDO1-691
- CDR0000256915 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Male Breast Cancer
-
Centro Hospitalar Lisboa OcidentalInstituto Nacional de Medicina Legal e Ciências Forenses, Delegação do SulUnknownMale Breast Cancer | Female Breast Cancer
-
University of WashingtonNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast CancerUnited States
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Organon and CoInstitute for Applied Economics and Health Research ApsCompleted
-
German Breast GroupPfizerCompletedMale Breast CancerGermany
-
Salah Azaïz Cancer InstituteUnknownMale Breast CancerTunisia
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States