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Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Antoinette R. Tan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

040504

NCT ID:

NCT00323063

Start Date:

May 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

Cooper Hospital/University Medical CenterCamden, New Jersey  08103
UMDNJ University HospitalNewark, New Jersey  07103
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Jersey Shore Cancer Center at Jersey Shore University Medical CenterNeptune, New Jersey  07754-0397
Mountainside HospitalMontclair, New Jersey  07042
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201