Clinical trial NCT00890305: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
FOLFOX chemotherapy
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 32 months
Secondary outcomes:
measure: Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.
timeFrame: 32 months
measure: Anti tumor activity of the antibody.
timeFrame: 32 months
measure: Objective response rate by RECIST.
timeFrame: 32 months
measure: Progression-free survival rates.
timeFrame: 32 months
measure: Response duration.
timeFrame: 32 months
measure: Overall survival.
timeFrame: 32 months
measure: Tumor and immunological markers.
timeFrame: 32 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Cancer Center of Huntsville, PC
state: Alabama
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Gabrovo
country: Bulgaria
facility: MHAT "Dr. Tota Venkova"
city: Ruse
country: Bulgaria
facility: InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD
city: Shumen
country: Bulgaria
facility: InterDistrict Dispensary in Oncology Diseases with Stationary
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Tsaritza Joanna"
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment for Oncology
city: Varna
country: Bulgaria
facility: InterDistrict Dispensary of Oncology Diseases with Stationary
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,
city: Sheikhpura, Patna
country: India
facility: Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences
state: Bihar
city: Nagpur
country: India
facility: Cancer Clinic
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre, Opp.
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pappanaickenpalayam, Coimbatore
country: India
facility: G. Kuppuswamy Naidu Memorial Hospital
state: Tamilnadu
city: Chiclayo
country: Peru
facility: Hospital Almanzor Aguinaga Asenjo - Chiclayo
city: Lima
country: Peru
facility: Clinica Ricardo Palma
city: Piura
country: Peru
facility: Hospital Regional nivel III Cayetano Heredia Essalud Piura
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine/CAIMED Center
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Cluj-Napoca
country: Romania
facility: "Prof. Dr. Ion Chiricuţă" Institute of Oncology
city: Constanta
country: Romania
facility: Clinical Emergency Hospital - Oncology Department
city: Craiova
country: Romania
facility: Oncolab SRL, No. 1
city: Iasi
country: Romania
facility: Center of Medical Oncology
city: Oradea
country: Romania
facility: Clinical Hospital Pelican Oradea
city: Ploiesti
country: Romania
facility: No. 1 City Hospital
city: Suceava
country: Romania
facility: "Sf. Ioan cel Nou" Clinical Emergency County Hospital
city: Tg. Mures
country: Romania
facility: Clinic of Oncology - Radiotherapy
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Leonard B Saltz, MD
role: PRINCIPAL_INVESTIGATOR
References: