Full Text View
Tabular View
No Study Results Posted
Related Studies
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
This study is ongoing, but not recruiting participants.
First Received: November 22, 2005   Last Updated: December 6, 2008   History of Changes
Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00258388
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: custirsen sodium
Drug: docetaxel
Drug: prednisone
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Prednisone Docetaxel OGX-011
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258388

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Kim N. Chi, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000450846, CAN-NCIC-IND165, ONCOGENEX-OGX-011-03, FHCRC-6084, UWCC-UW-6084, UWCC-06-0499-H/D
Study First Received: November 22, 2005
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00258388     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Glucocorticoids
Recurrence
Docetaxel
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009