Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Leucovorin

Fluorouracil

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

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

Derek Jonker

Patricia Tang

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.

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

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

A Randomized Phase II Study of Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients With Metastatic Colorectal Cancer.

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.

Changes in CEA level from baseline to week 28 during treatment.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate =Proportion of (CR + PR) observed over all randomized patients.

Time from randomization to death from any cause or censored at the time of last known alive

Oncolytics Biotech

Canadian Cancer Trials Group

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

Folfox Plus Bevacizumab and Reolysin

Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.

Folfox Plus Bevacizumab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Canada

Region of Enrollment

0: Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5. Dead

ECOG Performance Status

Dr. Derek Jonker

Progression Free Survival

All patients who had CEA levels measures at baseline and week 28.

Changes in CEA Levels

Objective Response Rate

Overall Survival

Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m\^2 and leucovorin 400 mg/m\^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m\^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m\^2 over 46 hours) and reolysin 3x10\^10 TCID_50 over 1 hour on days 1-5 of cycle 2, 4, 6, 8 and alternate cycles thereafter.

Folfox plus Bevacizumab: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m\^2 and leucovorin 400 mg/m\^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m\^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m\^2 over 46 hours).

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer	NCT01622543	Colorectal Canc...	Folfox plus Bev... Folfox plus Bev...	18 Years -	Canadian Cancer Trials Group
Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer	NCT01622543	Colorectal Canc...	Folfox plus Bev... Folfox plus Bev...	18 Years -	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for folfox plus bevacizumab and reolysin