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New treatment option for Colon Cancer
Official title Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05806931
What this study is testing
What is TAS-102, oxaliplatin, irinotecan with bevacizumab?
TAS-102, oxaliplatin, irinotecan with bevacizumab is an investigational medicine, being studied as a potential treatment for colon cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan...
- Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be...
- 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).
You likely can't join if
- 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...
- 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).
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Elizabeth, New Jersey, United States
- Jersey City, New Jersey, United States
- Lakewood, New Jersey, United States
- Livingston, New Jersey, United States
- Long Branch, New Jersey, United States
- New Brunswick, New Jersey, United States
- Somerset, New Jersey, United States
- Toms River, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elizabeth, New Jersey, United States; Jersey City, New Jersey, United States; Lakewood, New Jersey, United States; Livingston, New Jersey, United States; Long Branch, New Jersey, United States; New Brunswick, New Jersey, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.