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Monoclonal Antibodies
Capecitabine + Bevacizumab + Atezolizumab for Colorectal Cancer
Phase 2
Waitlist Available
Led By Niharika Mettu
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Histologically confirmed colorectal cancer that is either clinically or histologically proven to be metastatic and has progressed on regimens containing a fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and an anti-EGFR antibody (if tumor is RAS wild-type), or where the treatment was not tolerated or contraindicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to first documentation of disease progression by recist v1.1, or death from any cause, assessed up to 20 months
Awards & highlights
Study Summary
This trial is testing capecitabine, bevacizumab, and atezolizumab as a possible treatment for colorectal cancer that has spread and is not responding to treatment.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that has not improved after treatment with certain chemotherapy and antibody drugs. Participants must have a good performance status, meaning they can carry out daily activities with minimal assistance. They should have acceptable blood counts, liver and kidney function, and cannot be pregnant or breastfeeding. Those who've had recent heart issues, strokes, uncontrolled hypertension, or significant bleeding are excluded.Check my eligibility
What is being tested?
The study tests if adding Atezolizumab to Capecitabine and Bevacizumab improves outcomes in refractory metastatic colorectal cancer. Patients will be randomly assigned to receive either the combination of all three drugs or just Capecitabine and Bevacizumab with a placebo instead of Atezolizumab.See study design
What are the potential side effects?
Possible side effects include high blood pressure from Bevacizumab; hand-foot syndrome (redness/pain/swelling), diarrhea from Capecitabine; fatigue, nausea from both; immune-related reactions like inflammation of organs could occur due to Atezolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My colorectal cancer has spread and worsened after standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to first documentation of disease progression by recist v1.1, or death from any cause, assessed up to 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to first documentation of disease progression by recist v1.1, or death from any cause, assessed up to 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Objective Response Rate
Overall Survival (OS)
The Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment (Toxicity)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (atezolizumab, bevacizumab, capecitabine)Experimental Treatment4 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo, bevacizumab, capecitabine)Active Control4 Interventions
Patients receive placebo IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,190 Total Patients Enrolled
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,003 Total Patients Enrolled
Niharika MettuPrincipal InvestigatorAcademic and Community Cancer Research United
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Capecitabine and bevacizumab are suitable treatments for me.I do not have any current infections, recent vaccinations, or other serious medical conditions.I do not have serious heart, stomach, blood, immune system or urinary problems.I am currently using, or have recently used, medications that affect my immune system.I am fully active or can carry out light work.I have recently taken certain medications.I have not had a demyelinating disease or another cancer in the last 3 years.My cancer can be measured and has grown in areas previously treated with radiation.I have no recent surgeries or wound healing issues.My colorectal cancer has spread and worsened after standard treatments.I recently had a stent placed or underwent an endoscopic procedure.I am currently breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (atezolizumab, bevacizumab, capecitabine)
- Group 2: Arm II (placebo, bevacizumab, capecitabine)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the most common diagnoses for which capecitabine is prescribed?
"Capecitabine has been shown to be an effective treatment for small cell lung cancer (sclc), recurrent platinum-resistant epithelial ovarian cancer, and other malignant neoplasms."
Answered by AI
Has the US food and drug administration given Capecitabine the green light?
"While there is some evidence that capecitabine is safe, it only received a score of 2 because this drug has not yet been proven effective."
Answered by AI
Do other research teams ever prescribe Capecitabine?
"At this time, there are a total of 954 ongoing clinical trials for the use of Capecitabine. Out of these, 271 are Phase 3 medical studies. The majority of research locations for Capecitabine are in Woolloongabba, Queensland; however, there are 45898 other sites hosting active trials for this medication."
Answered by AI
How many people are currently enrolled in this experiment?
"This particular trial is not currently admitting patients, but there are many other studies that might be of interest. There are 3348 clinical trials looking for participants who have colorectal carcinoma and 954 studies involving Capecitabine that are also actively recruiting."
Answered by AI
Can patients still sign up for this research project?
"Although this particular trial is not recruiting at the moment, according to clinicaltrials.gov, it was most recently edited on 1/5/2022. There are 4302 other studies that are currently looking for patients to enroll."
Answered by AI
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