Trial Title:
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
NCT ID:
NCT05806931
Condition:
Colon Cancer
Rectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Oxaliplatin
Irinotecan
Conditions: Keywords:
Sequential Combined TAS-102
Oxaliplatin
Irinotecan
Late-Line Metastatic Colorectal Cancer
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAS-102, oxaliplatin, irinotecan with bevacizumab
Description:
Participants will be treated with the study drugs until radiological evidence of disease
progression or until treatment discontinuation secondary to adverse events. TAS-OX
alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of
mCRC.
Arm group label:
Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab
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)
Detailed description:
This phase II trial will evaluate efficacy of TAS-OX alternating with TAS-IRI (sequential
TASOXIRI) with Bevacizumab, in the treatment of mCRC. Participants will be treated with
the study drugs until radiological evidence of disease progression or until treatment
discontinuation secondary to adverse events.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
1. Absolute neutrophil count (ANC) > 1.5 x 109/L
2. Hemoglobin > 9 g/dL
3. Platelets (PLT) > 70 x 109/L
4. AST/ALT < 5 x ULN
5. 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.
Exclusion Criteria:
- Participants who have previously received TAS-102.
- Grade 3 or higher peripheral neuropathy (functional impairment).
- Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)
- There are no specific exclusions for bevacizumab. Bevacizumab should be given unless
there are specific contraindications per the treating investigator, which should be
stated. If UPC is >1.0 (as above) hold bevacizumab until proteinuria resolves and
then start bevacizumab.
- Symptomatic CNS metastases requiring treatment.
- Other active malignancy within the last three years (except for non-melanoma skin
cancer or a non-invasive/in situ cancer).
- Pregnancy or breast feeding.
- Current therapy with other investigational agents.
- Active infection with body temperature > 38°C due to infection.
- Major surgery within prior four weeks (the surgical incision should be fully healed
prior to drug administration).
- Any anticancer therapy within prior two weeks of first dose of study drug.
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to TAS-102.
- Current therapy with other investigational agents or participation in another
clinical study or any investigational agent received within prior four weeks.
- Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade
1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for
Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia,
alopecia, skin pigmentation, and platinum-induced neurotoxicity).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Trinitas Hospital and Comprehensive Cancer Center
Address:
City:
Elizabeth
Zip:
07202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
RWJBarnabas Health Jersey City Medical Center
Address:
City:
Jersey City
Zip:
07302
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Address:
City:
Lakewood
Zip:
08701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Address:
City:
Livingston
Zip:
07039
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
RWJBarnabas Health - Monmouth Medical Center
Address:
City:
Long Branch
Zip:
07740
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster, MD
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital
Address:
City:
Somerset
Zip:
08873
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Facility:
Name:
RWJBarnabas Health - Community Medical Center
Address:
City:
Toms River
Zip:
08755
Country:
United States
Status:
Recruiting
Contact:
Last name:
Howard S. Hochster
Phone:
732-253-5618
Email:
howard.hochster@rutgers.edu
Start date:
May 17, 2023
Completion date:
May 1, 2027
Lead sponsor:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806931
