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

NCT00258388 | Completed Phase 2 DMC FDA Drug

• 7 other identifiers: I165CAN-NCIC-IND165ONCOGENEX-OGX-011-03FHCRC-6084UWCC-UW-6084UWCC-06-0499-H/DCDR0000450846
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 13

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (2)

• Toxicity

  2 years

• Time to treatment failure

  2 years

Study Arms (2)

OGX011, Docetaxel and Prednisone

ACTIVE COMPARATOR

Drug: custirsen sodium; Drug: docetaxel; Drug: prednisone

Docetaxel plus prednisone

ACTIVE COMPARATOR

Drug: docetaxel; Drug: prednisone

Interventions

custirsen sodium 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)

OGX011, Docetaxel and Prednisone

docetaxel DRUG

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

Docetaxel plus prednisone; OGX011, Docetaxel and Prednisone

prednisone DRUG

5mg PO BID

Docetaxel plus prednisone; OGX011, Docetaxel and Prednisone

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (13)

University of Washington

Seattle, Washington, 98109, United States

Location

Tom Baker Cancer Centre

Calgary, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, T6G 1Z2, Canada

Location

QEII Health Sciences Center

Halifax, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, L8V 5C2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, V1Y 5L3, Canada

Location

London Regional Cancer Program

London, N6A 4L6, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, H2L 4M1, Canada

Location

Atlantic Health Sciences Corporation

Saint John, E2L 4L2, Canada

Location

Odette Cancer Centre

Toronto, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, M5G 2M9, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, R3E 0V9, Canada

Location

Related Publications (1)

• 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.

  PMID: 20733135 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kim N. Chi, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: September 28, 2005
• Primary Completion: November 8, 2007
• Study Completion: January 18, 2011
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (12)