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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
The Cancer Center of Huntsville, PC
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00890305
Pfizer
Completed
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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