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

NCT ID: NCT00323063

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-01
• Study Completion Date: 2016-06-20

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (Gemcitabine Hydrochloride)

Patients receive gemcitabine hydrochloride IV on days 3 and 10.

Group Type: ACTIVE_COMPARATOR

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

Arm II (Gemcitabine Hydrochloride + Imatinib)

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

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

imatinib mesylate

Intervention Type: DRUG

Given orally

Interventions

gemcitabine hydrochloride

Given IV

Intervention Type: DRUG

imatinib mesylate

Given orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Deborah Toppmeyer, MD

Chief, Division of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah R. Toppmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Cooper Hospital/University Medical Center

Camden, New Jersey, United States

Rutgers Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States

Mountainside Hospital

Montclair, New Jersey, United States

Jersey Shore Cancer Center at Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

NJ Medical School

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000539445

Identifier Type: OTHER

Identifier Source: secondary_id

0220060081

Identifier Type: OTHER

Identifier Source: secondary_id

NJ1105

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00520

Identifier Type: OTHER

Identifier Source: secondary_id

040504

Identifier Type: OTHER

Identifier Source: secondary_id

0220060081

Identifier Type: -

Identifier Source: org_study_id