A Study of Reolysin For Patients With Advanced/Metastatic Breast 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:
NCT01656538
First received: July 31, 2012
Last updated: August 11, 2014
Last verified: February 2014
  Purpose

Researchers doing this study want to evaluate the side effects of Reolysin when given together with paclitaxel. As these drugs have not been given together before, 6-9 patients will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Paclitaxel
Drug: Reolysin
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 For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To investigate additional potential measures of efficacy including Objective response rate, overall survival (OS) and CTC counts.

  • Tumour and tissue response of potential molecular factors [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs (including EGFR and KRAS status) and serial blood samples

  • Number of patients with adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To determine the tolerability and toxicity of reolysin and paclitaxel when given in combination.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel plus Reolysin
Paclitaxel given weekly on days 1, 8, 15 every 4 weeks plus reolysin days 1, 2, 8, 9, 15 and 16.
Drug: Paclitaxel Drug: Reolysin
Active Comparator: Paclitaxel
Paclitaxel given weekly on days 1, 8 and 15 every 4 weeks.
Drug: Paclitaxel

Detailed Description:

The purpose of the randomized part of this study is to find out if giving Reolysin in combination with paclitaxel can offer better results than standard therapy with paclitaxel.

  Eligibility

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

Inclusion Criteria:

  • Patients must have a histological/cytological diagnosis of metastatic breast cancer.
  • Patients must have advanced and/or metastatic disease, for which no curative therapy exists and for which systemic therapy is indicated.
  • All patients must have an available formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) and must have provided informed consent for the release of the block, as well as for CTC and blood samples for correlative studies and banking.

For patients who have not had a tissue biopsy within the last 12 months, a repeat biopsy is strongly recommended but is not mandated providing that archival tissue is available.

• Re-biopsy is recommended if > 1 year since last biopsy.

  • Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).

All patients must have measurable disease as defined by RECIST 1.1.

The criteria for defining measurable disease are as follows:

Chest xray ≥ 20mm CT/MRI scan (with slice thickness <5mm) ≥10mm -> longest diameter Physical exam (using calipers) ≥ 10mm Lymph nodes by CT scan ≥ 15mm -> measured in short axis

  • ECOG performance of 0, 1 or 2.
  • Age ≥ 18 years of age
  • Previous Therapy

Surgery:

Previous major surgery is permitted provided that it has been at least 21days prior to patient randomization and that wound healing has occurred.

Chemotherapy:

Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease unless:

  1. they have relapsed within 6 months of completion of adjuvant chemotherapy or
  2. they have received taxane and/or anthracycline containing adjuvant chemotherapy Palliative therapy for breast cancer (chemotherapy, targeted, hormonal) is permitted but no more than three prior chemotherapy regimens are permissible.

Other Therapy:

Patients may have received other therapies including immunotherapy, or with signal transduction inhibitors.

Patients must have recovered from all reversible toxicity related to prior chemotherapy and have adequate washout from prior chemotherapy, and investigational agents as follows:

longest of one of the following.

  • two weeks
  • standard cycle length of prior regimen (i.e 21 days for doxorubicin q3 weeks)
  • 5 half-lives for investigational drugs.

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.

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

Hematology:

Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/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 ≤ 3 x ULN (Note: ≤ 5 x ULN if documented liver metastasis)

  • 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 with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection.
  • 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 contraindications to treatment with paclitaxel and/or neuropathy > grade 1.
  • Women must be post-menopausal, surgically sterile or use two reliable forms of contraception while on study and for 6 months after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to randomization and must not be lactating. Men must be surgically sterile or use a barrier method of contraception.
  • Concurrent treatment with other investigational drugs or anti-cancer therapy.
  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: NCT01656538

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

Locations
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard    250 712-3900 ext 686657      
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Karen Gelmon    604 877-6000 ext 2032      
BCCA - Vancouver Island Cancer Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Doran Ksienski    250 519-5500      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sukhbinder Dhesy-Thind    905 387-9495 ext 64431      
Cancer Centre of Southeastern Ontario at Kingston Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Mihaela Mates    613 549-2631 ext 4503      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Susan Dent    613 737-7700 ext 70167      
Canada, Quebec
McGill University - Dept. Oncology Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Nathaniel Bouganim    514 398-8307      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Vamsee Torri    306 766-2691      
Sponsors and Collaborators
NCIC Clinical Trials Group
Oncolytics Biotech
Investigators
Study Chair: Vanessa Bernstein BCCA - Vancouver Island Centre
Study Chair: Susan Ellard BCCA-Cancer Ctr., Southern Interior
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01656538     History of Changes
Other Study ID Numbers: I213
Study First Received: July 31, 2012
Last Updated: August 11, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014