Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00003236
• Date of registration: 01/11/1999
• Primary sponsor: Eastern Cooperative Oncology Group
• Public title: Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer
• Scientific title: 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
• Date of first enrolment: May 1998
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00003236
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: William J. Gradishar, MD
• Affiliation: Robert H. Lurie Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Biological: ISIS 3521

Drug: ISIS 5132

Secondary ID(s)

CDR0000066108

ECOG-3197

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)