Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

NCIC Clinical Trials Group

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: prednisone

Drug: custirsen sodium

Drug: docetaxel

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00258388

ONCOGENEX-OGX-011-03 (Other Identifier)

I165

CDR0000450846 (Other Identifier)

UWCC-UW-6084 (Other Identifier)

FHCRC-6084 (Other Identifier)

CAN-NCIC-IND165 (Other Identifier)

UWCC-06-0499-H/D (Other Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, 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 and prednisone kill more tumor cells by making tumor cells less resistant to the drugs.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy.

Full description

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.

Enrollment

82 patients

Sex

Male

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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