OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Metastatic or locally advanced disease

• Not curable with standard therapy

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• Lesion must be outside of the previously irradiated field

• If the sole site of disease is in a previously irradiated field, there must be evidence of disease progression or new lesions in the irradiated field

• No known CNS metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Platelet count ≥ 100,000/mm^3

• Absolute granulocyte count ≥ 1,500/mm^3

• PTT, PT, and INR normal

• No known bleeding disorder

Hepatic

• Bilirubin normal

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No significant cardiac dysfunction

Immunologic

• No active uncontrolled infection

• No history of serious allergic reaction to taxanes, including paclitaxel or docetaxel

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No preexisting neuropathy ≥ grade 2

• No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

• No other serious medical condition or illness that would preclude study participation

• No significant neurological disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior trastuzumab (Herceptin^®) allowed

Chemotherapy

• Recovered from prior chemotherapy

• At least 6 months since prior adjuvant chemotherapy (taxanes allowed)

• At least 4 weeks since prior chemotherapy for advanced disease

• No prior taxanes for advanced disease

• No more than 1 prior chemotherapy regimen for advanced disease

• No other concurrent chemotherapy

Endocrine therapy

• At least 1 week since prior hormonal therapy

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• Low-dose, nonmyelosuppressive radiotherapy allowed within 4 weeks before study entry at the discretion of the investigator

• No prior radiotherapy ≥ 30% of functioning bone marrow

• No concurrent radiotherapy

Surgery

• At least 3 weeks since prior major surgery and recovered (wound healing must have occurred)

Other

• More than 4 weeks since prior investigational agents or new anticancer therapy

• No concurrent therapeutic anticoagulation therapy except low-dose oral anticoagulant therapy (i.e., 1 mg of oral warfarin once a day) or low molecular weight heparin

• No other concurrent investigational therapy

• No other concurrent cytotoxic therapy