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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by (Responsible Party): | NCIC Clinical Trials Group |
| 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
| Enrollment: | 82 |
| Study Start Date: | June 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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) 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
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Systemic chemotherapy is indicated, due to disease progression while receiving androgen-ablative therapy (i.e., hormone-refractory disease)
Androgen ablative therapy must have included either medical or surgical castration
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
At least 4 weeks since prior external beam radiotherapy except low-dose, nonmyelosuppressive radiotherapy
Surgery
Other
Contacts and 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 | |
| Study Chair: | Kim N. Chi, MD | British Columbia Cancer Agency |
More Information
| 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 |
| Study First Received: | November 22, 2005 |
| Last Updated: | September 27, 2011 |
| Health Authority: | Canada: Health Canada |
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Prednisone Docetaxel |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |