- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247984
A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer
March 9, 2022 updated by: Aiping Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
An Efficacy and Safety Study of mXELIRI Versus. FOLFIRI + Bevacizumab Therapy as First-line Chemotherapy in Metastatic Colorectal Cancer
This is a Phase II, multicenter,randomized, two arms, open-labeled, controlled clinical trial.
This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer (mCRC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase II, multicenter,randomized, two arms, open-labeled, controlled clinical trial.
This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI in not previously treated patients with metastatic colorectal cancer (mCRC).
In experimental group, untreated patients with metastatic colorectal cancer will receive Irinotecan 150 mg/m2 (D1, q2w) , Xeloda 2000mg/m2 (D1-10, q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment.
While in control group, patients with metastatic colorectal cancer will receive Irinotecan 180 mg/m2 (D1, q2w) , CF 300mg/m2 (D1 q2w), 5FU 400mg/m2, D1 2400 mg/m2, civgtt 44h (q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment.The primary endpoint is progression-free survival.
Overall survival, Objective Response rate, adverse event and life quality will be assessed as secondary outcomes.
Study Type
Interventional
Enrollment (Actual)
264
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China, 100021
- Cancer Hospital & Institute, Chinese Academy of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent;
- ECOG≤1;
- Age≥18;
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no previous chemotherapy or molecular targeted therapy;
- At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
- life expectancy >12 weeks;
- Adequate bone marrow and organ function. Hb≥9 G/L; Absolute neutrophil ≥ 1.5 G/L; PLT ≥100 G/L ;ALT/AST ≤2 ULN or ≤5ULN with liver metastases;ALP ≤2.5 ULN or ≤5ULN with liver metastases or ≤10ULN with bone metastases ; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
- Urinary protein excretion < 2+ (dipstick). If > or equal 2+ proteinuria is detected with dipstick, a 24-hour period urine test will be performed and the result should be < or equal to 1 g/24 hours to permit the inclusion of the patient in the clinical trial.
Exclusion Criteria:
- Pregnant or lactating women;
- Sexually active women (of childbearing potential) or men unwilling to adopt an effective method of birth control during the course of the study;
- Previous treatment with Irinotecan or anti-VEGF antibodies;
- Any previous malignancy within 5 years prior to study entry, except for cured basal cell carcinoma of skin or carcinoma-in-situ of the uterine cervix;
- History of acute coronary syndromes (including myocardial infarction and unstable angina) within 6 months prior to study entry, or history or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA);
- Uncontrolled hypertension and severe arrhythmia requiring drug treatment;
- Present with non-healing fractures or wounds of skin;
- History of previous abdominal fistula, gastrointestinal perforation or intra-abdominal abscesses within 6 months before randomization;
- Major surgery, open surgical biopsy or significant traumatic injury within 4 weeks or needle biopsy within 7 days before randomization before randomization;
- Evidence or history of bleeding diathesis or coagulopathy;
- Known or suspected allergy or hypersensitivity to any component of Bevacizumab, xeloda, irinotecan, or 5-FU/LV;
- Clinical or radiological evidence of CNS metastases;
- History of unexpected serious adverse events to fluoropyrimidine treatments or known dihidropyrimidine dehydrogenase (DPD) deficiency;
- Patients subjected to organ allografts who require immunosuppressive treatment;
- Prior adjuvant or neoadjuvant treatment for metastatic colorectal cancer is allowed, as long as it has concluded at least 6 months before beginning the treatment of the study;
- If adjuvant treatment has previously been administered, the patients cannot have shown progression of the disease during treatment nor during the 6 months following termination thereof;
- Prior radiotherapy is allowed if it has not been administered in the target lesions selected for this study, unless progression of said lesions in the irradiated field is documented, and as long as treatment has concluded at least 4 weeks before beginning the study;
- Prior surgical treatment of the disease in stage IV is allowed;
- Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the initial study treatment or thrombolytic agents. Low dose of warfarin is allowed, with an INR ≤ 1.5;
- Subject requiring chronic use of high dose aspirin (> 325 m/day) or non-steroidal anti-inflammatory treatment ;
- Received any investigational drug or agent/ procedure, i.e. participation in another treatment trial within 4 weeks of randomisation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: mXELIRI+ Bevacizumab
|
5 mg/kg intravenously administered on day 1 of a 2-week cycle.
Other Names:
2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.
Other Names:
180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
Other Names:
150 mg/m2 intravenously administered on day 1 of a 2-week cycle.
Other Names:
|
ACTIVE_COMPARATOR: FOLFIRI + Bevacizumab
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5 mg/kg intravenously administered on day 1 of a 2-week cycle.
Other Names:
180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
Other Names:
150 mg/m2 intravenously administered on day 1 of a 2-week cycle.
Other Names:
400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.
Other Names:
300 mg/m2 intravenously administered on day 1 of a 2-week cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 6 Months
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Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.
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6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: 6 Months
|
Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.
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6 Months
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Overall survival (OS)
Time Frame: 1 Year
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Time from the date of enrollment to death from any cause.
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1 Year
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Incidence of Adverse Events
Time Frame: 6 Months
|
The incidence of adverse events as graded by NCI-CTCAE v 4.0.
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6 Months
|
Quality of life (QoL) Questionnaire
Time Frame: 6 Months
|
Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
|
6 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2018
Primary Completion (ACTUAL)
April 1, 2021
Study Completion (ACTUAL)
January 31, 2022
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (ACTUAL)
January 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2022
Last Update Submitted That Met QC Criteria
March 9, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Fluorouracil
- Capecitabine
- Bevacizumab
- Irinotecan
Other Study ID Numbers
- NCC-000583
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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