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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response measured by RECIST criteria after accrual of 14 evaluable patients

Safety Issue:

No

Principal Investigator

Stephen Chia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

United States: Federal Government

Study ID:

I164

NCT ID:

NCT00258375

Start Date:

June 2005

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

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