Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal 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:
NCT01622543
First received: June 12, 2012
Last updated: June 4, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.


Condition Intervention Phase
Colorectal Cancer
Drug: Folfox plus Bevacizumab and reolysin
Drug: Folfox plus Bevacizumab
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 FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients With Metastatic Colorectal Cancer.

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    Effect of reolysin in combination with standard FOLFOX6 chemotherapy on the progression free survival of patients with advanced or metastatic colorectal cancer.


Secondary Outcome Measures:
  • Changes in CEA levels [ Time Frame: Baseline and at 19 months ] [ Designated as safety issue: No ]
    To investigate additional potential measures of efficacy.

  • Objective response rate [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    To investigate additional potential measures of efficacy

  • Overall survival [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    The effect of both treatments on overall survival

  • Molecular response [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    Potential molecular factors predictive of response by assessment of archival tumour tissue (and serial blood samples)

  • Quality of Life [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    To explore the Quality of Life (as measured by the EORTC QLQC30).

  • Tolerability and toxicity in patients [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
    Determine the effect of reolysin and Folfox6/bevacizumab in patients.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Folfox plus Bevacizumab and Reolysin Drug: Folfox plus Bevacizumab and reolysin
FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
Active Comparator: Folfox plus Bevacizumab Drug: Folfox plus Bevacizumab
FOLFOX6/bevacizumab given every 14 days.

Detailed Description:

Researchers doing this study also want to evaluate the side effects of reolysin when given together with FOLFOX6/ bevacizumab.

  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 diagnosis of colorectal adenocarcinoma.
  • All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies and must have provided informed consent for the release of the block.
  • 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 X-ray ≥ 20 mm CT/MRI scan (with slice thickness of < 5 mm) ≥ 10 mm longest diameter Physical exam (using calipers) ≥ 10 mm Lymph nodes by CT scan ≥ 15 mm measured in short axis

  • Patients must have advanced and or metastatic disease, for which no curative therapy exists and for which systemic therapy is indicated.
  • 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 may NOT have received any prior cytotoxic chemotherapy for advanced or metastatic disease. Prior adjuvant fluoropyrimidine-based therapy is permitted provided completed at least one year prior to enrolment and the regimen did not include oxaliplatin or bevacizumab. Exceptions may be made for low dose chemotherapy given as a radiosensitizing agent.

Other Therapy:

Patients may have received other therapies including immunotherapy, or with signal transduction inhibitors, providing that the patient has recovered from all reversible drug related toxicity (with the exception of alopecia) and adequate washout period has been met.

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) Proteinuria ≤ grade 2 (using spot testing; if grade 3 repeat with mid stream urine collection for 24 hours to confirm grade 0, 1 or 2)

  • 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.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life (EORTC QLQ-C30) in either English or French. The baseline assessment must already have been completed. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. The baseline assessment must be completed within 14 days prior to randomization.
  • 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 had prior treatment with oxaliplatin or bevacizumab, who have contraindications to treatment with 5FU (for e.g. known DPD deficiency or severe cardiac disease), and or neuropathy > grade 1.
  • Patients 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: NCT01622543

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: Patricia Tang    403 521-3490      
Canada, British Columbia
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Hagen Kennecke    604 877-6000 ext 2032      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: John Goffin    905 387-9495      
Cancer Centre of Southeastern Ontario at Kingston Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Anna Tomiak    613 549-6666 ext 4503      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Stephen Welch    519 685-8640      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Derek Jonker    613 737-7700 ext 70168      
Univ. Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Eric (Xueyu) Chen    416 946-2263      
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Yoo-Joung Ko    416 480-5847      
Canada, Quebec
McGill University - Dept. Oncology Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Thierry Alcindor    514 934-1934 ext 43118      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Haji Ibrahim Chalchal    306 766-2691      
Sponsors and Collaborators
NCIC Clinical Trials Group
Oncolytics Biotech
Investigators
Study Chair: Derek Jonker Ottawa Health Research Institute - General Division
Study Chair: Patricia Tang Tom Baker Cancer Centre, Calgary, Canada
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01622543     History of Changes
Other Study ID Numbers: I210
Study First Received: June 12, 2012
Last Updated: June 4, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014