Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

Phase 2

Completed

Brief Summary: This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.

Detailed Description: The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.

Recruitment & Eligibility

Inclusion Criteria

Patient's age is 18 years or older, both genders.
Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
ECOG performance status ≤ 1
At least 4 weeks from prior major surgery or radiotherapy.
Life expectancy >3 months
Hematology: ANC ≥ 1.5X109/L; Platelets >100x109/L.
Adequate Renal function
Adequate Hepatic functions
Normal Cardiac function

Exclusion Criteria

Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
Patients on concurrent anti cancer therapy other than that allowed in the study.
Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
Presence of clinically apparent or suspected brain metastasis.
Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
Serious active infection at the time of pre-study screening.
Active or history of autoimmune disorders/conditions.
Women who are pregnant or lactating
Concurrent active malignancy.
Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
Patients with history of life threatening allergic reactions to food or drugs
Patients with symptomatic peripheral neuropathy> Grade 1.
Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.

Arm && Interventions

Group	Intervention	Description
CT-011 in combination with FOLFOX	CT-011	CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
CT-011 in combination with FOLFOX	FOLFOX	CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
FOLFOX	FOLFOX	FOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.	32 months

Secondary Outcome Measures

Name	Time	Method
Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.	32 months
Anti tumor activity of the antibody.	32 months
Objective response rate by RECIST.	32 months
Progression-free survival rates.	32 months
Response duration.	32 months
Overall survival.	32 months
Tumor and immunological markers.	32 months

Locations (31): The Cancer Center of Huntsville, PC
🇺🇸
Huntsville, Alabama, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States
Signal Point Clinical Research Center
🇺🇸
Middletown, Ohio, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸
Lubbock, Texas, United States
MHAT "Dr. Tota Venkova"
🇧🇬
Gabrovo, Bulgaria
InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD
🇧🇬
Ruse, Bulgaria
InterDistrict Dispensary in Oncology Diseases with Stationary
🇧🇬
Shumen, Bulgaria
Multiprofile Hospital for Active Treatment "Tsaritza Joanna"
🇧🇬
Sofia, Bulgaria
Specialized Hospital for Active Treatment for Oncology
🇧🇬
Sofia, Bulgaria
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The Cancer Center of Huntsville, PC
🇺🇸Huntsville, Alabama, United States