Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.

• Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.

• Progression of disease must be documented on the most recent scan.

• Presence of measurable disease

• RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).

• Age 18 years or older.

• ECOG performance status 0-1.

• Life expectancy of at least three months.

• Participants with adequate organ function:

‣ Absolute neutrophil count (ANC) \> 1.5 x 109/L

⁃ Hemoglobin \> 9 g/dL

⁃ Platelets (PLT) \> 70 x 109/L

⁃ AST/ALT \< 5 x ULN

⁃ Albumin within normal limits for institution

• Women who are nursing and discontinue nursing prior to enrollment in the program.

• Ability to take oral medication (i.e., no feeding tube).

• Participant able and willing to comply with study procedures as per protocol.

• Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.

Locations
United States
New Jersey
Trinitas Hospital and Comprehensive Cancer Center
RECRUITING
Elizabeth
RWJBarnabas Health Jersey City Medical Center
RECRUITING
Jersey City
RWJBarnabas Health - Monmouth Medical Center Southern Campus
RECRUITING
Lakewood
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
RECRUITING
Livingston
RWJBarnabas Health - Monmouth Medical Center
RECRUITING
Long Branch
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITING
Somerset
RWJBarnabas Health - Community Medical Center
RECRUITING
Toms River
Contact Information
Primary
Howard S. Hochster, MD
howard.hochster@rutgers.edu
732-253-5618
Time Frame
Start Date: 2023-05-17
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 50
Treatments
Experimental: Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab
Each treatment cycle will be fourteen days long. TAS-102 25 mg/m2 will be taken orally twice daily on days 1-5 of each cycle. Oxaliplatin 85 mg/m2 infusion will be given on day one for one cycle alternating with Irinotecan 150 mg/m2 infusion, which will be given on day one the next cycle.
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov