Reolysin Combined With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Metastatic Castration Resistant Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by NCIC Clinical Trials Group
Sponsor:
Collaborator:
Oncolytics Biotech
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01619813
First received: June 12, 2012
Last updated: September 16, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to find out if giving Reolysin in combination with docetaxel and prednisone can offer better results than standard therapy with docetaxel and prednisone.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel, Reolysin and Prednisone
Drug: Docetaxel and 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 Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Disease Progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy will be based on the lack of disease progression measured at 12 weeks.


Secondary Outcome Measures:
  • Effect of Docetaxel and Reolysin on circulating tumour cells [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Effect of docetaxel and Reolysin on the circulating tumour cell (CTC) favourable status (< 5 CTC per 7.5mL). Effect will be measured after 6 and 12 weeks of treatment.

  • PSA change rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Objective Response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Objective response rate (in patients with measurable disease at baseline)

  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Determine patient tolerability and toxicity of Reolysin and Docetaxel in combination [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Determine the effect of Reolysin and Docetaxel in combination in patients.

  • Prognostic/Predictive molecular response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Explore potential molecular factors which might be prognostic/predictive of response (tumour, CTCs, serial blood samples).


Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel, Reolysin and Prednisone Drug: Docetaxel, Reolysin and Prednisone
Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly beginning on day 1, cycle 1. Reolysin will be delivered as a 1-hour infusion days 1-5. On day 1 of each cycle, when both agents are given, the docetaxel will be given first. Prednisone 5 mg BID will be given beginning day 1. Each cycle is 3 weeks in length.
Active Comparator: Docetaxel and Prednisone Drug: Docetaxel and Prednisone
Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly. Prednisone 5mg BID will be given beginning Day 1. Each cycle is 3 weeks in length.

Detailed Description:

Researchers doing this study also want to evaluate the side effects of Reolysin when given together with docetaxel and prednisone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histological diagnosis of adenocarcinoma of the prostate.
  • All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies.
  • Presence of clinically and/or radiologically documented disease (measureable or non-measurable). All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). Patients with elevated PSA only are not eligible.
  • Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present.
  • Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration.

Progression is defined as one or both of the following:

PSA Progression:

A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥2 ng/ml and must be performed no longer than 7 days prior to trial randomization. Patients who have had prolonged responses to combined androgen blockade should be evaluated for a withdrawal response prior to confirming eligibility OR

Radiological Progression:

defined as the development of new metastatic lesions or progression in target disease (RECIST 1.1) with a stable or rising PSA.

  • The PSA must be ≥ 5 ng/ml at the time of study entry.
  • ECOG performance of 0, 1 or 2.
  • Age ≥ 18 years of age.
  • Patients must have a life expectancy of ≥ 12 weeks.
  • Previous Therapy

Surgery:

Previous major surgery is permitted provided that it has been at least 14 days prior to patient randomization and that wound healing has occurred.

Chemotherapy:

Patients may NOT have received any prior cytotoxic chemotherapy for recurrent/metastatic castration resistant prostate cancer. Prior docetaxel treatment is not permitted unless it was provided on an adjuvant therapy protocol more than 12 months prior to study enrolment.

Hormonal Therapy:

Prior hormone therapy is required. Patients must be castrate resistant and have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate level of testosterone must be present. Prior therapy with CYP17 inhibitors (e.g. abiraterone, ketoconazole) or novel anti-androgens (e.g. MDV3100) is permitted.

Radiation:

Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG. Prior strontium is not permitted.

  • Laboratory Requirements (must be done within 7 days prior to randomization)

Hematology:

Granulocytes (AGC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L

Biochemistry:

Serum creatinine ≤ 1.5 x ULN Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to conditions such as Gilbert's disease) ALT and AST ≤ 1.5 x ULN

  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.

Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.

  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.

Exclusion Criteria:

  • Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for ≥ 3 years.(Please call NCIC CTG if any questions about the interpretation of this criterion).
  • Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
  • Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
  • Patients with history of central nervous system metastases or untreated spinal cord compression.
  • Patients who have had prior treatment with docetaxel for advanced/metastatic disease.
  • Men who are not sterile unless they use an adequate method of birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619813

Contacts
Contact: Lesley Seymour 613-533-6430 lseymour@ctg.queensu.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Nimira Alimohamed    403 521-3445      
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Scott North    780 432-8762      
Canada, British Columbia
BCCA - Abbotsford Centre Recruiting
Abbotsford, British Columbia, Canada, V2S 0C2
Contact: Muhammad Zulfiqar    604 351-4710 ext 644744      
BCCA - Cancer Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard    250 712-3900 ext 686657      
BCCA - Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Lyly H. Le    604 930-4017      
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Bernhard Eigl    604 877-6000 ext 2707      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sebastien Hotte    905 387-9495      
Cancer Centre of Southeastern Ontario at Kingston Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Richard W. Gregg    613 549-6666 ext 4509      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Eric W. Winquist    519 685-8261      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Christina Canil    613 737-7700 ext 70180      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Muhammad Salim    306 766-2691      
Sponsors and Collaborators
NCIC Clinical Trials Group
Oncolytics Biotech
Investigators
Study Chair: Bernhard Eigl BCCA Vancouver
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01619813     History of Changes
Other Study ID Numbers: I209
Study First Received: June 12, 2012
Last Updated: September 16, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 22, 2014