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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258375
Enrollment
15
Registered
2005-11-24
Start date
2005-10-21
Completion date
2008-09-22
Last updated
2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer

Brief 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.

Detailed description

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.

Interventions

DRUGdocetaxel

Sponsors

NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Objective response measured by RECIST criteria after accrual of 14 evaluable patients

Secondary

MeasureTime frame
Toxicity

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026