Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer

NCT01622543 | Completed Phase 2 Results DMC

• 1 other identifier: I210
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  19 months

Secondary Outcomes (3)

• Changes in CEA Levels

  Baseline and at 28 weeks

• Objective Response Rate

  19 months

• Overall Survival

  From date of randomization to death from any cause or censored at the time of last known alive, assessed up to 49 months

Study Arms (2)

Folfox plus Bevacizumab and Reolysin

ACTIVE COMPARATOR

Drug: Folfox plus Bevacizumab and reolysin

Folfox plus Bevacizumab

ACTIVE COMPARATOR

Drug: Folfox plus Bevacizumab

Interventions

Folfox plus Bevacizumab and reolysin DRUG

FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter

Folfox plus Bevacizumab and Reolysin

Folfox plus Bevacizumab DRUG

FOLFOX6/bevacizumab given every 14 days.

Folfox plus Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 enrollment 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.

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 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Oncolytics Biotech: collaborator

Study Sites (10)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, 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

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (2)

• Jonker DJ, Tang PA, Kennecke H, Welch SA, Cripps MC, Asmis T, Chalchal H, Tomiak A, Lim H, Ko YJ, Chen EX, Alcindor T, Goffin JR, Korpanty GJ, Feilotter H, Tsao MS, Theis A, Tu D, Seymour L. A Randomized Phase II Study of FOLFOX6/Bevacizumab With or Without Pelareorep in Patients With Metastatic Colorectal Cancer: IND.210, a Canadian Cancer Trials Group Trial. Clin Colorectal Cancer. 2018 Sep;17(3):231-239.e7. doi: 10.1016/j.clcc.2018.03.001. Epub 2018 Mar 8.

  PMID: 29653857 RESULT

• Provencher DM, Gallagher CJ, Parulekar WR, Ledermann JA, Armstrong DK, Brundage M, Gourley C, Romero I, Gonzalez-Martin A, Feeney M, Bessette P, Hall M, Weberpals JI, Hall G, Lau SK, Gauthier P, Fung-Kee-Fung M, Eisenhauer EA, Winch C, Tu D, MacKay HJ. OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer. Ann Oncol. 2018 Feb 1;29(2):431-438. doi: 10.1093/annonc/mdx754.

  PMID: 29186319 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol; Bevacizumab; reolysin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Derek Jonker
• Organization: The Ottawa Hospital - Cancer Centre

djonker@ottawahospital.on.ca

613-737-7700

Study Officials

• Derek Jonker

  Ottawa Health Research Institute - General Division

  STUDY CHAIR

• Patricia Tang

  Tom Baker Cancer Centre, Calgary, Canada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: June 12, 2012
• First Posted: June 19, 2012
• Study Start: October 26, 2012
• Primary Completion: January 18, 2017
• Study Completion: September 12, 2018
• Last Updated: August 23, 2023
• Results First Posted: December 13, 2019

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)