Clinical trial NCT02135887: A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage III Colorectal Cancer
Neutropenia
Keywords: Stage III Colorectal Cancer
Grade 4 Neutropenia
MB-6
Lead sponsor: Microbio Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.
timeFrame: 18 weeks
Secondary outcomes:
measure: Time to first Grade 4 Neutropenia
timeFrame: 18 weeks
measure: Incidence of Febrile Neutropenia
timeFrame: 18 weeks
measure: Incidence of Grade 3 or 4 Neutropenia
timeFrame: 18 weeks
measure: Change in Serum Creatinine level
timeFrame: 18 weeks
measure: Health-Related Quality of Life (HRQoL) - QLQ-C30
timeFrame: 18 weeks
measure: Quality of Life -VAS on Fatigue, Constipation, Appetite
timeFrame: 18 weeks
measure: Compliance with Chemotherapy
timeFrame: 18 weeks
measure: Increase in Body Weight
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Microbio Co., Ltd.
Study officials:
affiliation: China Medical University Hospital
name: William Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: