Know Cancer

or
forgot password

A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer


OBJECTIVES:

Primary

- Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel
and prednisone with or without OGX-011 in patients with hormone-refractory locally
recurrent or metastatic prostate cancer.

Secondary

- Determine the objective response rate and duration in patients treated with these
regimens.

- Determine the safety and toxic effects of these regimens in these patients.

- Determine the overall and progression-free survival of patients treated with these
regimens.

OUTLINE: This is a multicenter, randomized, open-label study. Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive a loading dose of OGX-011 IV over 2 hours on days -7, -5, and
-3. Patients then receive OGX-011 IV over 2 hours on days 1, 8, and 15, docetaxel IV
over 1 hour on day 1, and oral prednisone twice daily on days 1-21. Treatment repeats
every 3 weeks for up to 10 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice
daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Metastatic or locally recurrent disease

- Not curable with standard therapy

- Systemic chemotherapy is indicated, due to disease progression while receiving
androgen-ablative therapy (i.e., hormone-refractory disease)

- Disease progression is defined as development of new metastatic lesions OR ≥ 2
consecutive rises in prostate-specific antigen (PSA) over a reference value

- Androgen ablative therapy must have included either medical or surgical
castration

- Castrate level of testosterone (≤ 1.7 nmol/L) required if treated with
medical androgen ablation

- Patients with documented disease progression while on peripheral antiandrogens
must also have documented PSA progression after stopping antiandrogens

- PSA ≥ 5 ng/mL

- No known CNS metastases

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- No known bleeding disorder

Hepatic

- PT and PTT or INR normal

- Bilirubin normal

- AST and ALT ≤ 1.5 times upper limit of normal (ULN)

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No significant cardiac dysfunction

Other

- Fertile patients must use effective contraception

- No pre-existing peripheral neuropathy ≥ grade 2

- No active, uncontrolled infection

- No significant neurological disorder that would preclude study compliance

- No history of other malignancies within the past 5 years except adequately treated
nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy

- No prior chemotherapy except estramustine and recovered

- No other concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- At least 4 weeks since prior antiandrogens (6 weeks for bicalutamide)

- Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued* or
restarted* during study treatment to maintain castrate levels of testosterone NOTE:
*For patients receiving LHRH agonist therapy prior to study entry

Radiotherapy

- At least 4 weeks since prior external beam radiotherapy except low-dose,
nonmyelosuppressive radiotherapy

- Must have had less than 25% of marrow irradiated

- No prior strontium chloride Sr 89

- No concurrent radiotherapy except low-dose, nonmyelosuppressive, palliative
radiotherapy

Surgery

- At least 2 weeks since prior major surgery

Other

- At least 4 weeks since prior investigational agent

- At least 4 weeks since prior anticancer therapy

- No concurrent therapeutic anticoagulants except low-dose oral anticoagulants (i.e., 1
mg warfarin) or low molecular weight heparin

- No other concurrent investigational agents

- No other concurrent cytotoxic therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Kim N. Chi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

I165

NCT ID:

NCT00258388

Start Date:

June 2005

Completion Date:

January 2011

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

University of WashingtonSeattle, Washington  98195