RECRUITING

Study of CtDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas

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Conditions

Colon AdenocarcinomaColorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

Official Title

Proof of Concept Study of CtDNA Guided Change in Treatment for Refractory Minimal Residual Disease in Colon Adenocarcinomas

Quick Facts

Study Start:2021-08-26
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04920032

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiation needed). Other histologies which are treated per NCCN guidelines for adjuvant colon cancer are eligible.
  2. 2. Must have Stage II, Stage III, or Stage IV colorectal cancer after curative intent resection eligible for adjuvant doublet chemotherapy for at least 3 months.
  3. 3. Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy
  4. 4. Age ≥ 18 years
  5. 5. Performance status: ECOG performance status ≤2
  6. 6. Life expectancy of greater than 3 months
  7. 7. Adequate organ and marrow function as defined below:
  8. 1. leukocytesL ≥ 3,000/mcL
  9. 2. absolute neutrophil count: ≥ 1,500/mcL
  10. 3. platelets: ≥ 80,000/mcl
  11. 4. total bilirubin: within normal institutional limits
  12. 5. AST(SGOT)/ALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present
  13. 6. creatinine: \<1.5 X ULN
  14. 8. The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because topoisomerase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  15. * Has not undergone a hysterectomy or bilateral oophorectomy; or
  16. * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  17. 9. Ability to swallow tablets
  18. 10. Ability to understand and the willingness to sign a written informed consent.
  1. 1. Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1
  2. 2. All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
  3. 3. Patients may not be receiving any other investigational agents.
  4. 4. Patients with known metastases.
  5. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in study.
  6. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. 7. Prior treatment with TAS-102 at any time or irinotecan within 90 days from enrollment.
  8. 8. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
  9. 9. Inability to comply with study and follow-up procedures as judged by the Investigator
  10. 10. Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. -

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
1-877-827-7883
ucstudy@uci.edu
University of California Irvine Medical
CONTACT

Principal Investigator

Farshid Dayyani, MD, PhD
PRINCIPAL_INVESTIGATOR
Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Farshid Dayyani, MD, PhD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

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 Registration Dates

Study Start Date2021-08-26
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-08-26
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Colon Adenocarcinoma
  • Colorectal Cancer