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Treatment Arm for Colorectal Cancer

Phase 2

Recruiting

Led By Syed Kazmi, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The eligible patient's tumors be classified as proficient in DNA mismatch repair (pMMR) by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2. Tumors with intact expression of all MMR proteins will be considered pMMR.

Histologically proven stage IV colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1- 2, M1). Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

Awards & highlights

Study Summary

This trial is studying the effects of a combination of drugs (ATRA, atezolizumab, and bevacizumab) as a potential treatment for advanced colorectal cancer. Participants

Who is the study for?

This trial is for adults over 18 with advanced stage IV colon adenocarcinoma. They must have tried at least two systemic chemotherapies and their tumors should be proficient in DNA mismatch repair or stable microsatellite status. Adequate organ function and certain blood levels are required.Check my eligibility

What is being tested?

The trial tests a combination of ATRA (pill form), Atezolizumab, and Bevacizumab (both via vein) on colorectal cancer patients to assess the benefits and side effects. Treatments occur every two weeks at UTSW outpatient centers.See study design

What are the potential side effects?

Potential side effects include reactions related to infusion, increased bleeding risk due to Bevacizumab, immune-related issues from Atezolizumab, and skin changes or headaches from ATRA.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is proficient in DNA repair, as shown by a specific test.

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My cancer is a type of colon cancer that has spread to other parts of my body.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate of of ATRA, bevacizumab and atezolizumab combination

Secondary outcome measures

Disease Control Rate of of ATRA, bevacizumab and atezolizumab combination

Frequency of adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment3 Interventions

ATRA orally 45 mg/m2 daily in 2 divided doses days 1-7, repeat every 14 days Atezolizumab IV D1, 840 mg every 14 days Bevacizumab IV D1, 10 mg/kg every 14 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5280

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,122 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,714 Total Patients Enrolled

Syed Kazmi, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

1 Previous Clinical Trials

44 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants receiving treatment in this particular study?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The study was initially posted on December 19th, 2023 and last updated on January 17th, 2024. The research team aims to enroll a total of 21 patients at one designated site."

Answered by AI

Are there any ongoing efforts to enroll patients in this current medical study?

"Indeed, clinicaltrials.gov provides information that confirms this study is actively seeking participants. The trial was initially posted on December 19, 2023 and recently updated on January 17, 2024. The research team aims to recruit a total of 21 patients from a single location."

Answered by AI

Has the treatment arm received official authorization from the FDA?

"Based on our evaluation at Power, the safety level of the Treatment Arm is rated as 2. This assessment aligns with it being a Phase 2 trial where there is limited data supporting its safety but no evidence yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of All-trans-retinoic Acid, Bevacizumab and Atezolizumab in Colorectal Cancer

Syed Kazmi 2023. "Clinical Trial of All-trans-retinoic Acid, Bevacizumab and Atezolizumab in Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999812.

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