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

NCT00258375 | Completed Phase 2 DMC

• 4 other identifiers: I164CAN-NCIC-IND164ONCOGENEX-OGX-011-06CDR0000450847
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Toxicity

Interventions

custirsen sodium DRUG

docetaxel DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (5)

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Chia S, Dent S, Ellard SL, et al.: A phase II trial of a second generation antisense oligonucleotide (ASO) to clusterin (OGX-011) in combination with docetaxel in metastatic breast cancer (MBC): NCIC-CTG IND 164 trial. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-3512, 2007.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Stephen Chia, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: October 21, 2005
• Primary Completion: February 23, 2007
• Study Completion: September 22, 2008
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)