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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: CT-011 Drug: FOLFOX	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by CureTech Ltd:

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. [ Time Frame: 32 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, tolerability, pharmacokinetics and immunogenicity of CT-011. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Anti tumor activity of the antibody. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Objective response rate by RECIST. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Progression-free survival rates. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Response duration. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Overall survival. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Tumor and immunological markers. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	168
Study Start Date:	May 2009
Study Completion Date:	March 2013
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 CT-011 in combination with FOLFOX chemotherapy	Drug: CT-011 A total of up to 9 doses of CT-011 (3 mg/kg) will be given. Drug: FOLFOX 24 cycles (every two weeks) of FOLFOX chemotherapy regimen. Drugs: Folinic acid, Fluorouracil, and Oxaliplatin
Active Comparator: 2 FOLFOX chemotherapy	Drug: FOLFOX 24 cycles (every two weeks) of FOLFOX chemotherapy regimen. Drugs: Folinic acid, Fluorouracil, and Oxaliplatin

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890305

Show 31 Study Locations

Sponsors and Collaborators

CureTech Ltd

Investigators

Principal Investigator:

Leonard B Saltz, MD

Memorial Sloan-Kettering Cancer Center

More Information

No publications provided

Responsible Party:	CureTech Ltd
ClinicalTrials.gov Identifier:	NCT00890305 History of Changes
Other Study ID Numbers:	CT-2008-01, 2009-014593-18
Study First Received:	April 28, 2009
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India Romania: National Medicines Agency Bulgaria: Bulgarian Drug Agency

Keywords provided by CureTech Ltd:

Metastatic colorectal cancer
FOLFOX chemotherapy

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Neoplasm Metastasis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Intestinal Neoplasms

Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013