Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2027-05-01

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Colon Cancer Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TAS-102, oxaliplatin, irinotecan with bevacizumab

Intervention Type DRUG

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.

Interventions

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TAS-102, oxaliplatin, irinotecan with bevacizumab

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.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No