Back to resultsStudy to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CT-011
FOLFOX
Sponsored by
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
Arm Type
Experimental
Active Comparator
Arm Label
CT-011 in combination with FOLFOX
FOLFOX
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.
Anti tumor activity of the antibody.
Objective response rate by RECIST.
Progression-free survival rates.
Response duration.
Overall survival.
Tumor and immunological markers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00890305
Brief Title
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Official Title
Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic colorectal cancer, FOLFOX chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-011 in combination with FOLFOX
Arm Type
Experimental
Arm Description
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.
Arm Title
FOLFOX
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CT-011
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days.
mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours).
Primary Outcome Measure Information:
Title
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.
Time Frame
32 months
Secondary Outcome Measure Information:
Title
Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.
Time Frame
32 months
Title
Anti tumor activity of the antibody.
Time Frame
32 months
Title
Objective response rate by RECIST.
Time Frame
32 months
Title
Progression-free survival rates.
Time Frame
32 months
Title
Response duration.
Time Frame
32 months
Title
Overall survival.
Time Frame
32 months
Title
Tumor and immunological markers.
Time Frame
32 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard B Saltz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cancer Center of Huntsville, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
MHAT "Dr. Tota Venkova"
City
Gabrovo
Country
Bulgaria
Facility Name
InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD
City
Ruse
Country
Bulgaria
Facility Name
InterDistrict Dispensary in Oncology Diseases with Stationary
City
Shumen
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Tsaritza Joanna"
City
Sofia
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment for Oncology
City
Sofia
Country
Bulgaria
Facility Name
InterDistrict Dispensary of Oncology Diseases with Stationary
City
Varna
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,
City
Varna
Country
Bulgaria
Facility Name
Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences
City
Sheikhpura, Patna
State/Province
Bihar
ZIP/Postal Code
800 014
Country
India
Facility Name
Cancer Clinic
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Curie Manavata Cancer Centre, Opp.
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
G. Kuppuswamy Naidu Memorial Hospital
City
Pappanaickenpalayam, Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641037
Country
India
Facility Name
Hospital Almanzor Aguinaga Asenjo - Chiclayo
City
Chiclayo
Country
Peru
Facility Name
Clinica Ricardo Palma
City
Lima
Country
Peru
Facility Name
Hospital Regional nivel III Cayetano Heredia Essalud Piura
City
Piura
Country
Peru
Facility Name
Ponce School of Medicine/CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
"Prof. Dr. Ion Chiricuţă" Institute of Oncology
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Clinical Emergency Hospital - Oncology Department
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Oncolab SRL, No. 1
City
Craiova
ZIP/Postal Code
200535
Country
Romania
Facility Name
Center of Medical Oncology
City
Iasi
Country
Romania
Facility Name
Clinical Hospital Pelican Oradea
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
No. 1 City Hospital
City
Ploiesti
Country
Romania
Facility Name
"Sf. Ioan cel Nou" Clinical Emergency County Hospital
City
Suceava
Country
Romania
Facility Name
Clinic of Oncology - Radiotherapy
City
Tg. Mures
ZIP/Postal Code
540141
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
We'll reach out to this number within 24 hrs