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

NCT ID: NCT00890305

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT-011 in combination with 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.

Group Type: EXPERIMENTAL

CT-011

Intervention Type: DRUG

FOLFOX

Intervention Type: DRUG

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).

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.

Group Type: ACTIVE_COMPARATOR

FOLFOX

Intervention Type: DRUG

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).

Interventions

CT-011

Intervention Type: DRUG

FOLFOX

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient's age is 18 years or older, both genders.

2. 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.

3. ECOG performance status ≤ 1

4. At least 4 weeks from prior major surgery or radiotherapy.

5. Life expectancy >3 months

6. Hematology: ANC ≥ 1.5X109/L; Platelets >100x109/L.

7. Adequate Renal function

8. Adequate Hepatic functions

9. Normal Cardiac function

Exclusion Criteria

1. Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.

2. Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.

3. Patients on concurrent anti cancer therapy other than that allowed in the study.

4. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids

5. Presence of clinically apparent or suspected brain metastasis.

6. Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.

7. Serious active infection at the time of pre-study screening.

8. Active or history of autoimmune disorders/conditions.

9. Women who are pregnant or lactating

10. Concurrent active malignancy.

11. Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.

12. Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.

13. Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.

14. Patients with history of life threatening allergic reactions to food or drugs

15. Patients with symptomatic peripheral neuropathy> Grade 1.

16. Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medivation, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard B Saltz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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

Rousse, , 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

InterDistrict Dispensary of Oncology Diseases with Stationary

Varna, , Bulgaria

Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,

Varna, , Bulgaria

Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences

Sheikhpura, Patna, Bihar, India

Cancer Clinic

Nagpur, Maharashtra, India

Curie Manavata Cancer Centre, Opp.

Nashik, Maharashtra, India

Ruby Hall Clinic

Pune, Maharashtra, India

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, India

G. Kuppuswamy Naidu Memorial Hospital

Pappanaickenpalayam, Coimbatore, Tamil Nadu, India

Hospital Almanzor Aguinaga Asenjo - Chiclayo

Chiclayo, , Peru

Clinica Ricardo Palma

Lima, , Peru

Hospital Regional nivel III Cayetano Heredia Essalud Piura

Piura, , Peru

Ponce School of Medicine/CAIMED Center

Ponce, , Puerto Rico

Fundacion de Investigacion de Diego

Santurce, , Puerto Rico

"Prof. Dr. Ion Chiricuţă" Institute of Oncology

Cluj-Napoca, , Romania

Clinical Emergency Hospital - Oncology Department

Constanța, , Romania

Oncolab SRL, No. 1

Craiova, , Romania

Center of Medical Oncology

Iași, , Romania

Clinical Hospital Pelican Oradea

Oradea, , Romania

No. 1 City Hospital

Ploieşti, , Romania

"Sf. Ioan cel Nou" Clinical Emergency County Hospital

Suceava, , Romania

Clinic of Oncology - Radiotherapy

Tg. Mures, , Romania

Countries

United States; Bulgaria; India; Peru; Puerto Rico; Romania

Other Identifiers

2009-014593-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-2008-01

Identifier Type: -

Identifier Source: org_study_id