RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TAS-102 with oxaliplatin, alternating with TAS-102 and irinotecan, plus bevacizumab. It looks at how well treatment keeps cancer under control and how long it takes to grow. It is for adults with colon cancer that has spread and has worsened after standard treatment, or who could not tolerate that treatment.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older with stage IV colon cancer confirmed by a tissue test. Standard treatments must have failed or caused side effects that required stopping them.
  • Cancer must be measurable, and the latest scan must show that it has worsened.
  • Tumor tests called RAS and MMR must be done, or tumor tissue must be available for testing.
  • Must be fully active or able to do light work, and expected to live at least 3 months.
  • Blood cell counts, liver tests, and albumin, a blood protein, must meet the study's limits.
  • Must be able to take medicine by mouth without a feeding tube.
  • If nursing, must stop before joining the study.
  • Must be able and willing to follow study steps and sign a form agreeing to take part.

Who can't join

  • Past treatment with TAS-102, or an allergy to similar drugs.
  • Severe nerve damage that limits daily activities, or past inability to tolerate irinotecan because of uncontrolled diarrhea.
  • Severe allergic reactions to oxaliplatin or irinotecan, or milder oxaliplatin reactions not controlled with medicine given beforehand.
  • Cancer spread to the brain or spinal cord that causes symptoms and needs treatment; or another active cancer in the past 3 years, except non-melanoma skin cancer or cancer that has not invaded nearby tissue.
  • Pregnancy, breastfeeding, or an active infection causing a fever above 38°C.
  • Major surgery in the past 4 weeks, or cancer treatment within 2 weeks before the first study dose. Surgical wounds must be fully healed.
  • Current treatment with an experimental drug, participation in another clinical study, or use of an experimental drug in the past 4 weeks.
  • Ongoing moderate or worse side effects from earlier treatment, except low red blood cells, hair loss, skin color changes, or nerve damage from platinum drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (9)

NJ