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

NCT ID: NCT00258375

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-21
• Study Completion Date: 2008-09-22

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

custirsen sodium

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Chia, MD

Role: STUDY_CHAIR

British Columbia Cancer Agency

Locations

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

Other Identifiers

CAN-NCIC-IND164

Identifier Type: OTHER

Identifier Source: secondary_id

ONCOGENEX-OGX-011-06

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000450847

Identifier Type: OTHER

Identifier Source: secondary_id

I164

Identifier Type: -

Identifier Source: org_study_id