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

NCT00890305 | Completed Phase 2 DMC

• 2 other identifiers: CT-2008-012009-014593-18
• Study Type: interventional
• Target: 171
• Locations: 6 countries
• Sites: 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.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancer; FOLFOX chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

CT-011 in combination with FOLFOX

EXPERIMENTAL

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.

Drug: CT-011; Drug: FOLFOX

FOLFOX

ACTIVE COMPARATOR

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.

Drug: FOLFOX

Interventions

CT-011 DRUG

CT-011 in combination with FOLFOX

FOLFOX 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).

CT-011 in combination with FOLFOX; FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medivation, Inc.: lead

Study Sites (31)

The Cancer Center of Huntsville, PC

Huntsville, Alabama, 35801, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10017, United States

Location

Signal Point Clinical Research Center

Middletown, Ohio, 45042, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

MHAT "Dr. Tota Venkova"

Gabrovo, Bulgaria

Location

InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD

Rousse, Bulgaria

Location

InterDistrict Dispensary in Oncology Diseases with Stationary

Shumen, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Tsaritza Joanna"

Sofia, Bulgaria

Location

Specialized Hospital for Active Treatment for Oncology

Sofia, Bulgaria

Location

InterDistrict Dispensary of Oncology Diseases with Stationary

Varna, Bulgaria

Location

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

Varna, Bulgaria

Location

Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences

Sheikhpura, Patna, Bihar, 800 014, India

Location

Cancer Clinic

Nagpur, Maharashtra, 440012, India

Location

Curie Manavata Cancer Centre, Opp.

Nashik, Maharashtra, 422004, India

Location

Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411004, India

Location

G. Kuppuswamy Naidu Memorial Hospital

Pappanaickenpalayam, Coimbatore, Tamil Nadu, 641037, India

Location

Hospital Almanzor Aguinaga Asenjo - Chiclayo

Chiclayo, Peru

Location

Clinica Ricardo Palma

Lima, Peru

Location

Hospital Regional nivel III Cayetano Heredia Essalud Piura

Piura, Peru

Location

Ponce School of Medicine/CAIMED Center

Ponce, 00716, Puerto Rico

Location

Fundacion de Investigacion de Diego

Santurce, 00909, Puerto Rico

Location

"Prof. Dr. Ion Chiricuţă" Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Clinical Emergency Hospital - Oncology Department

Constanța, 900591, Romania

Location

Oncolab SRL, No. 1

Craiova, 200535, Romania

Location

Center of Medical Oncology

Iași, Romania

Location

Clinical Hospital Pelican Oradea

Oradea, 410469, Romania

Location

No. 1 City Hospital

Ploieşti, Romania

Location

"Sf. Ioan cel Nou" Clinical Emergency County Hospital

Suceava, Romania

Location

Clinic of Oncology - Radiotherapy

Tg. Mures, 540141, Romania

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

pidilizumab; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Leonard B Saltz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 8, 2015

Record last verified: 2015-06

Locations

IN (6); PE (3); PR (2); US (5); BU (7); RO (8)