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

NCT ID: NCT00258388

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-28
• Study Completion Date: 2011-01-18

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OGX011, Docetaxel and Prednisone

Group Type: ACTIVE_COMPARATOR

custirsen sodium

Intervention Type: DRUG

640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle)

Subsequent cycles:

weekly on days 1, 8, 15 (3 week cycles)

docetaxel

Intervention Type: DRUG

75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)

prednisone

Intervention Type: DRUG

5mg PO BID

Docetaxel plus prednisone

Group Type: ACTIVE_COMPARATOR

docetaxel

Intervention Type: DRUG

75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)

prednisone

Intervention Type: DRUG

5mg PO BID

Interventions

custirsen sodium

640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle)

Subsequent cycles:

weekly on days 1, 8, 15 (3 week cycles)

Intervention Type: DRUG

docetaxel

75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)

Intervention Type: DRUG

prednisone

5mg PO BID

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim N. Chi, MD

Role: STUDY_CHAIR

British Columbia Cancer Agency

Locations

University of Washington

Seattle, Washington, United States

Tom Baker Cancer Centre

Calgary, , Canada

Cross Cancer Institute

Edmonton, , Canada

QEII Health Sciences Center

Halifax, , Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, , Canada

BCCA - Cancer Centre for the Southern Interior

Kelowna, , Canada

London Regional Cancer Program

London, , Canada

CHUM - Hopital Notre-Dame

Montreal, , Canada

Atlantic Health Sciences Corporation

Saint John, , Canada

Odette Cancer Centre

Toronto, , Canada

Univ. Health Network-Princess Margaret Hospital

Toronto, , Canada

BCCA - Vancouver Cancer Centre

Vancouver, , Canada

CancerCare Manitoba

Winnipeg, , Canada

Countries

United States; Canada

References

Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.

Reference Type: RESULT

PMID: 20733135 (View on PubMed)

Other Identifiers

CAN-NCIC-IND165

Identifier Type: OTHER

Identifier Source: secondary_id

ONCOGENEX-OGX-011-03

Identifier Type: OTHER

Identifier Source: secondary_id

FHCRC-6084

Identifier Type: OTHER

Identifier Source: secondary_id

UWCC-UW-6084

Identifier Type: OTHER

Identifier Source: secondary_id

UWCC-06-0499-H/D

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000450846

Identifier Type: OTHER

Identifier Source: secondary_id

I165

Identifier Type: -

Identifier Source: org_study_id