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

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ClinicalTrials.gov Identifier: NCT02135887
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Microbio Co Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment
Stage III Colorectal Cancer Neutropenia 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.

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Study Type : Observational
Estimated Enrollment : 184 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : November 4, 2013
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Folinic acid; Fluorouracil ; Oxaliplatin




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


Secondary Outcome Measures :
  1. Time to first Grade 4 Neutropenia [ Time Frame: 18 weeks ]

    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).


  2. Incidence of Febrile Neutropenia [ Time Frame: 18 weeks ]
    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.

  3. Incidence of Grade 3 or 4 Neutropenia [ Time Frame: 18 weeks ]
    The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) <1000/mm3.

  4. Change in Serum Creatinine level [ Time Frame: 18 weeks ]
    Any change in Serum Creatinine level during the chemotherapy period

  5. Health-Related Quality of Life (HRQoL) - QLQ-C30 [ Time Frame: 18 weeks ]
    Health-Related Quality of Life (HRQoL) - QLQ-C30 should be completed at baseline, day 71 and end of study.

  6. Quality of Life -VAS on Fatigue, Constipation, Appetite [ Time Frame: 18 weeks ]
    Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.

  7. Compliance with Chemotherapy [ Time Frame: 18 weeks ]
    The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.

  8. Increase in Body Weight [ Time Frame: 18 weeks ]
    Any increased body weight during the chemotherapy period.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135887


Contacts
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Contact: William Chen, M.D. 886-4-22052121 ext 1638 wtchen@mail.cmuh.org.tw

Locations
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Taiwan
Microbio Co., Ltd. Recruiting
Taipei, Taiwan
Contact: Clinical Project Manager    886-2-2703-1298 ext 191    mbclinical@microbio.com.tw   
Sponsors and Collaborators
Microbio Co Ltd
Investigators
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Principal Investigator: William Chen, M.D. China Medical University Hospital
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Responsible Party: Microbio Co Ltd
ClinicalTrials.gov Identifier: NCT02135887    
Other Study ID Numbers: MB104CLCT02
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Keywords provided by Microbio Co Ltd:
Stage III Colorectal Cancer
Grade 4 Neutropenia
MB-6
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neutropenia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Leucovorin
Folic Acid
Fluorouracil
Oxaliplatin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents