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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| 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 |
- Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Time to treatment failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| 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
|
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 |
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| 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
Additional Information:
No publications provided by NCIC Clinical Trials Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by 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 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 |
ClinicalTrials.gov processed this record on May 19, 2013