- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04380103
A Phase I/II Study of XELOXIRI and Bevacizumab as First-line Treatment in Metastatic Colorectal Cancer
May 5, 2020 updated by: Lin Yang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Phase I/II Study of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab as a First-line Therapy for Patients With Metastatic Colorectal Cancer
The phase I/II study was designed to evaluate if the regimen of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab is a superior first-line option for patients with metastatic colorectal cancer(mCRC) in terms of safety and efficacy.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Recent studies have shown that the triplet-drug regimen FOLFOXIRI (irinotecan/oxaliplatin/fluorouracil) can further improves survival benefit for patients with metastatic colorectal cancer(mCRC) compared to standard two-drug regimens in first-line therapy, especially when combined with bevacizumab.
However, the increased toxicities of FOLFOXIRI limited its usage.
Capecitabine demonstrates a superior efficacy and safety than fluorouracil, so we designed this trial to evaluate if the XELOXIRI plus bevacizumab can be a better alternative to FOLFOXIRI plus bevacizumab.
The phase I study is to determine the safety and the recommended phase II dose (RP2D) of XELOXIRI plus Bevacizumab.
In the phase II study, we aim to determine the efficacy of the regimen as first-line therapy for mCRC and explore potential molecular biomarkers (genomes, circulating tumor cell) for toxicity forecasting or efficacy monitoring.
Study Type
Interventional
Enrollment (Anticipated)
106
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: M.D
- Phone Number: 13681015148 13681015148
- Email: lyang69@sina.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College
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Beijing, China
- Recruiting
- National Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
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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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with histologically confirmed metastatic colorectal adenocarcinoma;
- Age 18-80 years old;
- Eastern Cooperation Oncology Group (ECOG) performance score(<2);
- At least one measurable lesion for disease assessment according to RECIST version 1.1;
- Able to take oral medications;
- Previous fluoropyrimidine-based adjuvant or neoadjuvant chemotherapy was allowed only when it ended ≥ 6 months before study enrollment;
- No previous therapy for mCRC;
- Adequate organ functions as assessed by the following laboratory requirements: Leukocytes≥3.0x109/L, absolute neutrophil count≥1.5x109/L, platelet count≥100x109/L, hemoglobin≥9g/dL; serum bilirubin≤1.5x the upper limit of normal(ULN);Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤3x ULN; serum creatinine≤1.5x ULN; calculated creatinine clearance or 24 hour creatinine clearance ≥60ml/min.
- An expected survival of at least 3 months;
- Willingly provide written informed consent to study procedures.
Exclusion Criteria:
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- With a history of extensive enterotomy or pelvic radiation therapy; Suffering from grade 2 or higher symptomatic peripheral neuropathy according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
- Uncontrolled central nervous system metastasis, disseminated intravascular coagulation or active infection;
- With concurrent cancer distinct from colorectal adenocarcinoma except cured skin basal cell carcinoma and cervical carcinoma in situ;
- Undergone a major operation, open biopsy or major traumatic injury within 28 days before study enrollment or have potential to receive major operation during the trial;
- Received central venous access device within 2 days before study enrollment;
- Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure ≤New York Heart Association (NYHA) class 2 or uncontrolled hypertension.
- With positive urine protein and 24-hour urinary protein content>1g;
- Have a tendency of bleeding or clotting;
- With nasty open wounds, ulcers or fractures;
- Current or recent treatment of anticoagulants, antiplatelet agent or nonsteroidal anti-inflammatory drugs, while aspirin of daily dose less than 325mg is allowed.
- With any illness or medical conditions that may jeopardize the patient's compliance or interfere the analyses or judgements of study results;
- Pregnancy or lactation at the time of study entry;
- With fertility but refuse to contraception.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: XELOXIRI/Bevacizumab
drugs: Irinotecan, Oxaliplatin, Capecitabine, Bevacizumab bevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7, administered every 2 week for 12 cycles, after 12 cycles, administer bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy.
|
bevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7 repeated every 2 week for 12 cycles, after 12 cycles, bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy repeated every 2 week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recommended phase 2 dose (RP2D)
Time Frame: up to 1 year
|
RP2D is determined according to DLT and MTD in the phase 1 study
|
up to 1 year
|
dose-limited toxicity (DLT)
Time Frame: up to 1 year
|
dose limited toxicities are evaluated in the phase I study according to CTCAE v5.0 and reviewed through the phase I study completion
|
up to 1 year
|
maximum tolerated dose (MTD)
Time Frame: up to 1 year
|
MTD is determined according to the DLT in the phase I study
|
up to 1 year
|
objective response rate (ORR)
Time Frame: up to 2 years
|
ORR is defined as the proportion of patients achieving complete response or partial response
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events (AEs)
Time Frame: though study completion, an average of 2 years
|
Adverse events assessments are computed and categorized according to the Common Toxicity Criteria of the National Cancer Institute, version 5.0
|
though study completion, an average of 2 years
|
progression-free survival (PFS)
Time Frame: though study completion, an average of 2 years
|
PFS is defined as the time from randomization to the earliest evidence of disease progression (per RECIST v1.1), or death from any cause
|
though study completion, an average of 2 years
|
overall survival (OS)
Time Frame: up to 5 years
|
OS is defined as the time from randomized to death from any cause or to last contact
|
up to 5 years
|
disease control rate (DCR)
Time Frame: up to 2 years
|
DCR is defined as the proportion of patients achieving complete response, partial response or having stable disease
|
up to 2 years
|
duration of response (DOR)
Time Frame: though study completion, an average of 2 years
|
DOR is defined as the length from the first response occured to disease progression
|
though study completion, an average of 2 years
|
time to response (TTR)
Time Frame: up to 2 years
|
TTR is defined as the length from randomization to the first response occured.
|
up to 2 years
|
the surgical resection rate of patients with liver-only metastases
Time Frame: up to 2 years
|
the percentage of patients with liver-only metastases undergoing surgical resections during the trial therapy
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lin Yang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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)
April 26, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
May 3, 2020
First Submitted That Met QC Criteria
May 5, 2020
First Posted (Actual)
May 8, 2020
Study Record Updates
Last Update Posted (Actual)
May 8, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Oxaliplatin
- Bevacizumab
- Irinotecan
Other Study ID Numbers
- NCC2271
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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