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Randomized Phase II Study of Human C-Raf Kinase Antisense Oligonucleotide Isis 5132 (CGP 69846A) or Human Pkc-Alpha Antisence Oligonucleotide ISIS 3521 (CGP 64128A) in Women With Previously Treated Matastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Randomized Phase II Study of Human C-Raf Kinase Antisense Oligonucleotide Isis 5132 (CGP 69846A) or Human Pkc-Alpha Antisence Oligonucleotide ISIS 3521 (CGP 64128A) in Women With Previously Treated Matastatic Breast Cancer


OBJECTIVES: I. Estimate the proportion of women with previously treated metastatic breast
cancer who are progression free at 4 months after receiving ISIS 5132 or ISIS 3521. II.
Determine duration of response to these treatment regimens in this patient population. III.
Evaluate toxicities and tolerability of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of prior therapies for metastatic breast cancer (1 vs 2). Patients are randomized to
one of two treatment arms. (Arm I closed 12/22/99) Arm I: Patients receive ISIS 5132 IV
continuously over 21 days. (closed 12/22/99) Arm II: Patients receive ISIS 3521 IV
continuously over 21 days. Treatment repeats every 4 weeks in the absence of disease
progression or unacceptable toxicity. After every 2 courses, patients are evaluated for
response. Patients are followed every 3 months for the first 2 years, every 6 months the
next 3 years, then annually thereafter.

PROJECTED ACCRUAL: A maximum of 68 patients (34 per arm) will be accrued in this study (Arm
I closed 12/22/99).

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the breast
Must have failed at least one but no more than two prior therapies for metastatic breast
cancer, including endocrine and chemotherapy Relapsing while receiving or within 6 months
of completing adjuvant chemotherapy Disease progression during or subsequent to the most
recent therapy Measurable and evaluable disease Bone is an evaluable site only No CNS
metastases Hormone receptor status: Estrogen receptor negative, positive, or unknown

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Any status
Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute
neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL AST/ALT less than 3 times upper limit of normal PTT
within normal limits Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active
congestive heart failure No poorly controlled hypertension At least 3 months since prior
myocardial infarction Other: No history of other malignant neoplasms, except curatively
treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the
cervix Not pregnant or nursing Negative pregnancy test, documented sterilization, or
postmenopausal status Fertile patients must use effective contraception No uncontrolled
nonmalignant systemic diseases (including active peptic ulcer and poorly controlled
diabetes mellitus) No underlying disease state associated with active bleeding No
unexplained abnormality of prothrombin time (e.g., warfarin therapy)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 28 days since prior chemotherapy Endocrine therapy: See Disease
Characteristics At least 28 days since prior hormonal therapy Radiotherapy: Not specified
Surgery: At least 2 weeks since major surgery Other: At least 28 days since prior use of
other investigational drugs No therapeutic anticoagulation with heparin

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

William J. Gradishar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066108

NCT ID:

NCT00003236

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611