Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

32 months

Safety Issue:

No

Principal Investigator

Leonard B Saltz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CT-2008-01

NCT ID:

NCT00890305

Start Date:

May 2009

Completion Date:

March 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Metastatic colorectal cancer
  • FOLFOX chemotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
University of South Florida Tampa, Florida  33612
Signal Point Clinical Research Center Middletown, Ohio  45042
The Cancer Center of Huntsville, PC Huntsville, Alabama  35801