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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CureTech Ltd
ClinicalTrials.gov Identifier:
NCT00890305
First received: April 28, 2009
Last updated: June 18, 2013
Last verified: June 2013

April 28, 2009
June 18, 2013
May 2009
May 2012   (final data collection date for primary outcome 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. [ Time Frame: 32 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00890305 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • 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: 1
    CT-011 in combination with FOLFOX chemotherapy
    Interventions:
    • Drug: CT-011
    • Drug: FOLFOX
  • Active Comparator: 2
    FOLFOX chemotherapy
    Intervention: Drug: FOLFOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
March 2013
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania,   India,   Peru,   Puerto Rico,   Bulgaria,   United States
 
NCT00890305
CT-2008-01, 2009-014593-18
Yes
CureTech Ltd
CureTech Ltd
Not Provided
Principal Investigator: Leonard B Saltz, MD Memorial Sloan-Kettering Cancer Center
CureTech Ltd
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP