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

NCIC Clinical Trials Group

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: docetaxel

Drug: custirsen sodium

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00258375

CAN-NCIC-IND164 (Other Identifier)

I164

ONCOGENEX-OGX-011-06 (Other Identifier)

CDR0000450847 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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