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Docetaxel and Prednisone With or Without OGX-011 in Treating Patients With Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

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ClinicalTrials.gov Identifier: NCT00258388
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : September 28, 2011
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: custirsen sodium Drug: docetaxel Drug: prednisone Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OGX011, Docetaxel and Prednisone Drug: 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)


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

Drug: prednisone
5mg PO BID

Active Comparator: Docetaxel plus prednisone Drug: docetaxel
75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)

Drug: prednisone
5mg PO BID




Primary Outcome Measures :
  1. Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 2 years ]
  2. Time to treatment failure [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258388


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Canada
Tom Baker Cancer Centre
Calgary, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Canada, T6G 1Z2
QEII Health Sciences Center
Halifax, Canada, B3H 1V7
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Canada, L8V 5C2
BCCA - Cancer Centre for the Southern Interior
Kelowna, Canada, V1Y 5L3
London Regional Cancer Program
London, Canada, N6A 4L6
CHUM - Hopital Notre-Dame
Montreal, Canada, H2L 4M1
Atlantic Health Sciences Corporation
Saint John, Canada, E2L 4L2
Odette Cancer Centre
Toronto, Canada, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Canada, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, Canada, V5Z 4E6
CancerCare Manitoba
Winnipeg, Canada, R3E 0V9
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Kim N. Chi, MD British Columbia Cancer Agency

Publications of Results:
Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00258388     History of Changes
Other Study ID Numbers: I165
CAN-NCIC-IND165
ONCOGENEX-OGX-011-03
FHCRC-6084
UWCC-UW-6084
UWCC-06-0499-H/D
CDR0000450846 ( Other Identifier: PDQ )
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal