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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258375
• Other study ID #: I164
• Secondary ID: CAN-NCIC-IND164O
• Status: Completed
• Phase: Phase 2
• Start date: October 21, 2005
• Est. completion date: September 22, 2008

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 22, 2008
• Est. primary completion date: February 23, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• custirsen sodium

• docetaxel

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	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	BCCA - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Country where clinical trial is conducted

Canada, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response measured by RECIST criteria after accrual of 14 evaluable patients
Secondary	Toxicity