Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic colorectal cancer, FOLFOX chemotherapy
Eligibility Criteria
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.
Sites / Locations
- The Cancer Center of Huntsville, PC
- University of South Florida
- Memorial Sloan-Kettering Cancer Center
- Signal Point Clinical Research Center
- Joe Arrington Cancer Research and Treatment Center
- MHAT "Dr. Tota Venkova"
- InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD
- InterDistrict Dispensary in Oncology Diseases with Stationary
- Multiprofile Hospital for Active Treatment "Tsaritza Joanna"
- Specialized Hospital for Active Treatment for Oncology
- InterDistrict Dispensary of Oncology Diseases with Stationary
- Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,
- Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences
- Cancer Clinic
- Curie Manavata Cancer Centre, Opp.
- Ruby Hall Clinic
- Deenanath Mangeshkar Hospital and Research Centre
- G. Kuppuswamy Naidu Memorial Hospital
- Hospital Almanzor Aguinaga Asenjo - Chiclayo
- Clinica Ricardo Palma
- Hospital Regional nivel III Cayetano Heredia Essalud Piura
- Ponce School of Medicine/CAIMED Center
- Fundacion de Investigacion de Diego
- "Prof. Dr. Ion Chiricuţă" Institute of Oncology
- Clinical Emergency Hospital - Oncology Department
- Oncolab SRL, No. 1
- Center of Medical Oncology
- Clinical Hospital Pelican Oradea
- No. 1 City Hospital
- "Sf. Ioan cel Nou" Clinical Emergency County Hospital
- Clinic of Oncology - Radiotherapy
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
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-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.