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Antimetabolite
Galunisertib + Chemotherapy for Rectal Cancer
Phase 2
Waitlist Available
Led By Todd Crocenzi, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically confirmed rectal adenocarcinoma, AJCC Stage IIA-IIIC or AJCC Stage IV appropriate for consideration of primary rectal tumor resection
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first)
Awards & highlights
Study Summary
This trial is testing a new drug to treat rectal cancer in combination with chemotherapy and radiation. Tissue and blood samples will also be collected to study the effectiveness of the drug and the immune system's response.
Who is the study for?
Adults with confirmed rectal adenocarcinoma stages IIA-IIIC or stage IV suitable for tumor removal can join. They must be in good enough health to undergo treatment, not have serious heart conditions, active infections, autoimmune diseases, or a recent history of other cancers. Participants should not be pregnant and must use approved contraception.Check my eligibility
What is being tested?
The ExIST study is testing the safety and effectiveness of LY2157299 combined with chemotherapy (Fluorouracil or Capecitabine) and radiation therapy in treating rectal cancer over an 8-week period. The trial will also analyze tumor and blood samples to predict treatment response.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to LY2157299, typical chemotherapy-related issues like nausea, fatigue, low blood counts leading to increased infection risk, as well as potential impacts from radiation such as skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My rectal cancer is confirmed and considered for surgery.
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I am able to get out of my bed or chair and move around.
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I am not currently experiencing any bleeding.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of pathologic response
Secondary outcome measures
Immunologic monitoring parameters
Immunoscore (utilizing tumor tissue)
MRI Parameters
Trial Design
1Treatment groups
Experimental Treatment
Group I: LY2157299 + Chemoradiation + SurgeryExperimental Treatment4 Interventions
Patients will receive a 14 day course of LY2157299. On day 15 patients will begin chemoradiation treatment with Capecitabine or Fluorouracil. On day 29, patients will undergo another fourteen day course of LY2157299 concurrent with their ongoing chemoradiation treatment. Six to ten weeks after completing their neoadjuvant therapy, patient will undergo a tumor specific mesorectal excision as per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY2157299
2011
Completed Phase 2
~460
Fluorouracil
2014
Completed Phase 3
~11540
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,485 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,510 Total Patients Enrolled
Todd Crocenzi, MDPrincipal InvestigatorProvidence Health & Services
2 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My rectal cancer is confirmed and considered for surgery.I have a history of heart disease.I have a weak immune system or need medication that affects my immune system.I am not currently experiencing any bleeding.I am 18 years old or older.I am able to get out of my bed or chair and move around.I am not taking strong CYP3A4 inhibitors or inducers.I have an aortic aneurysm.I understand the study's risks and its investigational nature despite my psychiatric history.I will not father a child during treatment and for 3 months after.I am currently on antibiotics for an infection.I have had radiation therapy to my pelvic area before.I was diagnosed with a solid tumor cancer within the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: LY2157299 + Chemoradiation + Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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