Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT)

NCT ID: NCT03727763

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2022-12-31

Brief Summary

This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FIVC group

Irinotecan 180mg/m2 iv gtt (14 days per course) leucovorin 400mg/m2 iv gtt (14 days per course) 5-fluorouracil 400mg/m2 iv (14 days per course) 5-fluorouracil 2400 mg/m2 46h (14 days per course) vemurafenib 960mg po bid cetuximab 500mg/m2 iv gtt (14 days per course)

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

960mg po bid

Cetuximab

Intervention Type: DRUG

500mg/m2 iv gtt (14 days per course)

Interventions

Vemurafenib

960mg po bid

Intervention Type: DRUG

Cetuximab

500mg/m2 iv gtt (14 days per course)

Intervention Type: DRUG

Other Intervention Names

PLX4032, RG7204; ERBITUX

Eligibility Criteria

Inclusion Criteria

• Patients have histologically or cytologically confirmed advanced or recurrent CRC;
• Patients with BRAV V600E mutation/KRAS WT based on the NGS or ARMS-PCR detection of tumor tissue;
• Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
• Patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy;
• Patients without a history of receiving vemurafenib or cetuximab;
• Patients with age of 18-75yr;
• Patients with a performance status of 0,1or 2 on the Eastern Cooperative Oncology Group.；
• Patients with Life expectancy of more than 12 weeks;
• Patients must have the ability to understand and sign the written informed consent voluntarily;
• Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.

Exclusion Criteria

• Patients with KRAS/NRAS mutation;
• Patients with major surgery or severe trauma within 4 weeks before the first medication;
• Patients with hypersensitivity to the components in the study protocol;；
• Patients who are ready to give birth or are pregnant.。
• Patients with brain metastases 。
• Bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows：

• Neutrophil count<1,500/mm3；
• Platelet count <80,000/mm3；
• Total bilirubin >1.5-times the upper limit of normal；
• ALT/AST>2.5-times the upper limit of normal for patients without liver metastases; (5.0-times the upper limit of normal for patients without liver metastases)
• Creatinine >1.5-times the upper limit of normal；
• Patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;；
• Patients without legal capacity or limited civil capacity;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhan Wang

A single center clinical study of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhan Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan-Sheng Zang, Prof

Role: CONTACT

doctorzangys@163.com

+8613816584620

Facility Contacts

Zhan Wang, Prof.

Role: primary

profoundamir@139.com

+8613916229609

References

Wang Z, Qin BD, Ye CY, Wang MM, Yuan LY, Dai WP, Sun L, Liu K, Qin WX, Jiao XD, Li XN, Zang YS. Cetuximab and vemurafenib plus FOLFIRI (5-fluorouracil/leucovorin/irinotecan) for BRAF V600E-mutated advanced colorectal cancer (IMPROVEMENT): An open-label, single-arm, phase II trial. Eur J Cancer. 2022 Mar;163:152-162. doi: 10.1016/j.ejca.2021.12.028. Epub 2022 Jan 21.

Reference Type: DERIVED

PMID: 35074651 (View on PubMed)

Other Identifiers

IMPROVEMENT

Identifier Type: -

Identifier Source: org_study_id