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A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer

Phase 2
20 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer

Inclusion Criteria:

1. Patient with histologically confirmed colorectal cancer and/or clinical evidence of

2. At least one measurable lesion either by computer tomography (CT) scan or magnetic
resonance imaging (MRI);

3. Aged 20 years old or above;

4. Eastern Cooperative Oncology Group (ECOG) performance status < 2;

5. Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x
109/L, platelets > 100 x 109/L);

6. Adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit,
creatinine < 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) < 2.5 x upper normal limit;

7. Patients willing to participate in the trial and giving written informed consent.

Exclusion Criteria:

1. Pregnant or lactating patients;

2. Patients (male or female) with reproductive potential not using adequate
contraceptive measures;

3. Patients with evidence of central nervous system metastasis;

4. Subject with active infection which requires systemic treatment of antibiotic,
antifungal, or antiviral agents

5. Current history of chronic diarrhea;

6. Other serious illness or medical conditions (e.g.: history of angina, myocardial

7. History of second primary malignancies except for adequately treated basal cell
carcinoma of the skin or carcinoma in situ of the cervix;

8. Concurrent treatment with any other anticancer therapy;

9. Patients with congestive heart failure (New York Heart Association Functional
Classification III or IV), epilepsy, or other significant medical conditions as
judged by the investigator;

10. Patients treated with another investigational drug within 4 weeks of entry into this

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint of this study is the best overall response (complete response + partial response)

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

William Chen, B.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

China Medical University Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

December 2011

Related Keywords:

  • Colorectal Cancer
  • A Phase II Trial of MB-6 plus FOLFOX4 for Metastatic Colorectal Cancer
  • Colorectal Neoplasms