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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response rate, in women with locally advanced or metastatic breast cancer. Secondary Determine the tolerability and toxicity of this regimen in these patients. Determine the time to progression and overall survival of patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of course 1 and on days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour on days 1 and 8 of all courses. Treatment repeats every 21 days* for up to 10 courses in the absence of disease progression or unacceptable toxicity. NOTE: *Course 1 is 28 days in length and all subsequent courses (courses 2-10) are 21 days in length. After completion of study treatment, patients are followed at 4 weeks and then periodically until disease progression. PROJECTED ACCRUAL: Approximately 42 patients will be accrued for this study.

Official Title
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A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: custirsen sodium
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: custirsen sodium|nan|
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response measured by RECIST criteria after accrual of 14 evaluable patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer