NCT01656538

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

February 20, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2018

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

3.7 years

First QC Date

July 31, 2012

Last Update Submit

August 3, 2023

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    24 months

Secondary Outcomes (3)

  • Response rate

    24 months

  • Tumour and tissue response of potential molecular factors

    24 months

  • Number of patients with adverse events

    24 months

Study Arms (2)

Paclitaxel plus Reolysin

EXPERIMENTAL

Paclitaxel given weekly on days 1, 8, 15 every 4 weeks plus reolysin days 1, 2, 8, 9, 15 and 16.

Drug: PaclitaxelDrug: Reolysin

Paclitaxel

ACTIVE COMPARATOR

Paclitaxel given weekly on days 1, 8 and 15 every 4 weeks.

Drug: Paclitaxel

Interventions

PaclitaxelDRUG
PaclitaxelPaclitaxel plus Reolysin
ReolysinDRUG
Paclitaxel plus Reolysin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • +25 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

  • Bernstein V, Ellard SL, Dent SF, Tu D, Mates M, Dhesy-Thind SK, Panasci L, Gelmon KA, Salim M, Song X, Clemons M, Ksienski D, Verma S, Simmons C, Lui H, Chi K, Feilotter H, Hagerman LJ, Seymour L. A randomized phase II study of weekly paclitaxel with or without pelareorep in patients with metastatic breast cancer: final analysis of Canadian Cancer Trials Group IND.213. Breast Cancer Res Treat. 2018 Jan;167(2):485-493. doi: 10.1007/s10549-017-4538-4. Epub 2017 Oct 13.

    PMID: 29027598RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxelreolysin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Vanessa Bernstein

    BCCA - Vancouver Island Centre

    STUDY CHAIR

  • Susan Ellard

    BCCA-Cancer Ctr., Southern Interior

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 3, 2012

Study Start

February 20, 2013

Primary Completion

November 18, 2016

Study Completion

February 14, 2018

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(7)