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

N

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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