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Status:

COMPLETED

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

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

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 doce...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 21 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 22 2008

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00258375

    Start Date

    October 21 2005

    End Date

    September 22 2008

    Last Update

    August 4 2023

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, Canada, V1Y 5L3

    2

    BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, Canada, V3V 1Z2

    3

    British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, Canada, N6A 4L6