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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
custirsen sodium
docetaxel
prednisone
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • QEII Health Sciences Center
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • BCCA - Cancer Centre for the Southern Interior
  • London Regional Cancer Program
  • CHUM - Hopital Notre-Dame
  • Atlantic Health Sciences Corporation
  • Odette Cancer Centre
  • Univ. Health Network-Princess Margaret Hospital
  • BCCA - Vancouver Cancer Centre
  • CancerCare Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

OGX011, Docetaxel and Prednisone

Docetaxel plus prednisone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity
Time to treatment failure

Full Information

First Posted
November 22, 2005
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00258388
Brief Title
Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2005 (Actual)
Primary Completion Date
November 8, 2007 (Actual)
Study Completion Date
January 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OGX011, Docetaxel and Prednisone
Arm Type
Active Comparator
Arm Title
Docetaxel plus prednisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
custirsen sodium
Intervention Description
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
Intervention Name(s)
docetaxel
Intervention Description
75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
5mg PO BID
Primary Outcome Measure Information:
Title
Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
2 years
Title
Time to treatment failure
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim N. Chi, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
BCCA - Cancer Centre for the Southern Interior
City
Kelowna
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
London Regional Cancer Program
City
London
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Univ. Health Network-Princess Margaret Hospital
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
ZIP/Postal Code
R3E 0V9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20733135
Citation
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.
Results Reference
result

Learn more about this trial

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

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