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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890305
• Other study ID #: CT-2008-01
• Secondary ID: 2009-014593-18
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: June 10, 2015
• Start date: May 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaRomania: National Medicines AgencyBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• CT-011

• 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).

Locations

Country	Name	City	State
Bulgaria	MHAT "Dr. Tota Venkova"	Gabrovo
Bulgaria	InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD	Ruse
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
India	Cancer Clinic	Nagpur	Maharashtra
India	Curie Manavata Cancer Centre, Opp.	Nashik	Maharashtra
India	G. Kuppuswamy Naidu Memorial Hospital	Pappanaickenpalayam, Coimbatore	Tamilnadu
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
India	Ruby Hall Clinic	Pune	Maharashtra
India	Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences	Sheikhpura, Patna	Bihar
Peru	Hospital Almanzor Aguinaga Asenjo - Chiclayo	Chiclayo
Peru	Clinica Ricardo Palma	Lima
Peru	Hospital Regional nivel III Cayetano Heredia Essalud Piura	Piura
Puerto Rico	Ponce School of Medicine/CAIMED Center	Ponce
Puerto Rico	Fundacion de Investigacion de Diego	Santurce
Romania	"Prof. Dr. Ion Chiricuta" Institute of Oncology	Cluj-Napoca
Romania	Clinical Emergency Hospital - Oncology Department	Constanta
Romania	Oncolab SRL, No. 1	Craiova
Romania	Center of Medical Oncology	Iasi
Romania	Clinical Hospital Pelican Oradea	Oradea
Romania	No. 1 City Hospital	Ploiesti
Romania	"Sf. Ioan cel Nou" Clinical Emergency County Hospital	Suceava
Romania	Clinic of Oncology - Radiotherapy	Tg. Mures
United States	The Cancer Center of Huntsville, PC	Huntsville	Alabama
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Signal Point Clinical Research Center	Middletown	Ohio
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medivation, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.		32 months	Yes
Secondary	Anti tumor activity of the antibody.		32 months	Yes
Secondary	Objective response rate by RECIST.		32 months	Yes
Secondary	Progression-free survival rates.		32 months	Yes
Secondary	Response duration.		32 months	Yes
Secondary	Overall survival.		32 months	Yes
Secondary	Tumor and immunological markers.		32 months	Yes