A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer. (MB-6)

The Purpose of This Study is to Evaluate the Effectiveness of MB-6 as Adjuvant Therapy in Reducing Neutropenia When Given Oxaliplatin-based Chemotherapy in Patients With Stage 3 Colorectal Cancer Previously Treated With Surgery.

This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.

Study Overview

• Status: Unknown
• Conditions: Neutropenia; Stage III Colorectal Cancer
• Intervention / Treatment: Drug: MB-6; Drug: Placebo

Detailed Description

The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.

• Study Type: Observational
• Enrollment (Anticipated): 184

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Microbio Co., Ltd.
    • Contact: Clinical Project Manager; Phone Number: 191 886-2-2703-1298; Email: mbclinical@microbio.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 184 patients with stage III colorectal cancer underwent surgery will be recruited into the study for receiving adjuvant therapy over 18 weeks.

Description

Inclusion Criteria:

1. Men or women 20 years of age or older.
2. Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
4. No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of screening.
6. Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count ≥100000/mm3.
7. Kidney function:Serum creatinine <2 mg/dL.
8. Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.
9. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
10. Men and women of childbearing potential must agree to employ adequate contraception during the study period.

Exclusion Criteria:

1. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
2. Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
3. Concurrent treatment with any other anticancer therapy.
4. Radiotherapy ≤14 days prior to randomization.
5. Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
6. Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator.
7. Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC >1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization.
8. Patient of child-bearing potential is evidently pregnant or is breast feeding.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MB-6+FOLFOX chemotherapy; MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks	Drug: MB-6; 6# TID with meal; Other Names: Folinic acid; Fluorouracil ; Oxaliplatin
Placebo+FOLFOX chemotherapy; Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks	Drug: Placebo; 6# TID with meal; Other Names: Folinic acid; Fluorouracil ; Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.	The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)<500/mm3	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first Grade 4 Neutropenia	To determine the time interval from randomization to the first episode of grade 4 Neutropenia. The analyses for incidence of study event will be conducted using logistic regression model method to adjust for gender and the regimen of chemotherapy (e.g., FOLFOX4 or FOLFOX6).	18 weeks
Incidence of Febrile Neutropenia	The febrile neutropenia is defined as an ANC <1000/mm3 and a single temperature ≥38.3 degree of C or a sustained temperature of ≥38.0 degree C for more than one hour.	18 weeks
Incidence of Grade 3 or 4 Neutropenia	The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) <1000/mm3.	18 weeks
Change in Serum Creatinine level	Any change in Serum Creatinine level during the chemotherapy period	18 weeks
Health-Related Quality of Life (HRQoL) - QLQ-C30	Health-Related Quality of Life (HRQoL) - QLQ-C30 should be completed at baseline, day 71 and end of study.	18 weeks
Quality of Life -VAS on Fatigue, Constipation, Appetite	Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.	18 weeks
Compliance with Chemotherapy	The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.	18 weeks
Increase in Body Weight	Any increased body weight during the chemotherapy period.	18 weeks

Collaborators and Investigators

• Sponsor: Microbio Co Ltd
• Investigators: Principal Investigator: William Chen, M.D., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2013
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Stage III Colorectal Cancer; Grade 4 Neutropenia; MB-6
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Colorectal Neoplasms; Neutropenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Hematinics; Fluorouracil; Oxaliplatin; Leucovorin; Levoleucovorin; Folic Acid
• Other Study ID Numbers: MB104CLCT02