TAS-102 + Oxaliplatin for Colon Cancer

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Investigational agents

Disqualifiers: Peripheral neuropathy, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Ongoing until disease progression or unacceptable toxicity

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of combining TAS-102 and oxaliplatin, both chemotherapy drugs, in treating stage IV colon cancer. These drugs aim to stop tumor cells from growing by killing them or preventing their spread. This trial suits individuals whose colon cancer has progressed despite standard treatments, such as fluorouracil and irinotecan. Participants must have confirmed, measurable cancer and must not have previously tried TAS-102. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other investigational agents or have had anticancer therapy within the last 3 weeks before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using TAS-102 and oxaliplatin together is generally safe for people. One study found no unexpected side effects when these drugs were given at normal doses, suggesting that patients can handle the treatment well. Another study demonstrated that this combination worked effectively as a third option for treating advanced colorectal cancer, with 77% of patients not experiencing disease progression. These results support the safety of using TAS-102 and oxaliplatin together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of TAS-102 and oxaliplatin for colon cancer because it offers a unique approach compared to current treatments like FOLFOX or FOLFIRI. TAS-102, an oral medication, contains trifluridine and tipiracil, which work together to disrupt cancer cell growth by interfering with DNA replication. Oxaliplatin, administered intravenously, enhances the treatment's effectiveness by damaging cancer cell DNA, making them more susceptible to TAS-102. This combination has the potential to improve outcomes by targeting cancer cells through multiple mechanisms, potentially leading to better control of the disease with a manageable treatment schedule.

What evidence suggests that TAS-102 and oxaliplatin could be effective for stage IV colon cancer?

In this trial, participants will receive a combination of TAS-102 and oxaliplatin. A previous study showed a 77% overall disease control rate for patients with metastatic colorectal cancer, indicating that most patients experienced either tumor reduction or disease stabilization. Another study found that patients could remain on this treatment for up to 19 months, demonstrating its long-term effectiveness. The treatment aims to stop cancer cells from growing and spreading. While effective, some patients experienced side effects such as low white blood cell counts and high blood pressure. Overall, this combination therapy has shown promise for managing advanced colon cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Howard S. Hochster

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for adults with stage IV colon cancer that's worsened after standard treatment. They should have had a reaction to previous treatments, measurable disease, specific genetic features (RAS mutation and MMR status), good physical function, and acceptable blood counts. They must not be pregnant or breastfeeding, have no major recent surgery or active infections, and can't have used TAS-102 before.

Inclusion Criteria

My stage IV colon cancer has worsened after standard treatment.

I stopped my cancer treatment due to severe side effects.

Progression of disease must be documented on the most recent scan

Exclusion Criteria

Pregnancy or breast feeding

I haven't had cancer treatment in the last 3 weeks.

You have had allergic reactions to similar medications like TAS-102 in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAS-102 orally twice daily on days 1-5 and oxaliplatin intravenously on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Ongoing until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oxaliplatin
• TAS-102

Trial Overview The study tests how well TAS-102 combined with oxaliplatin works in treating advanced colon cancer. It's a phase II trial where these chemotherapy drugs are given to see if they can stop cancer cells from growing by killing them or preventing their spread.

How Is the Trial Designed?

Group I: Treatment (TAS-102, oxaliplatin) Experimental Treatment 2 Interventions

Patients receive TAS-102 PO BID on days 1-5 and oxaliplatin IV over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

Approved in European Union as Eloxatin for:

• Colorectal cancer

Approved in United States as Eloxatin for:

• Colorectal cancer

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Oxaliplatin is a potent antineoplastic drug that works by blocking DNA replication and transcription, leading to cell death, and has shown greater efficacy than other platinum-based drugs like cisplatin in preclinical studies.

It is approved for treating metastatic colorectal cancer in several regions and shows promise in combination therapies with other agents, enhancing its effectiveness against various solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel combinations with oxaliplatin. Mani, S., Manalo, J., Bregman, D.[2022]

In a study involving 32 Chinese patients with metastatic colorectal cancer, the test formulation of trifluridine and tipiracil (FTD/TPI) was found to be bioequivalent to the reference formulation (Lonsurf®), indicating similar effectiveness and safety profiles.

The pharmacokinetic parameters, including maximum plasma concentration and area under the curve, for both formulations fell within the FDA's bioequivalence criteria, confirming that the test formulation can be used interchangeably with Lonsurf® in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bioequivalence study of trifluridine/tipiracil tablets in Chinese metastatic colorectal cancer patients under fed conditions. Su, HC., Min, J., Song, Y., et al.[2023]

In a study of 70 patients with metastatic colorectal cancer who had previously failed multiple therapies, TAS-102 demonstrated a median progression-free survival (PFS) of 6.0 months and an overall survival (OS) of 10.0 months, indicating its effectiveness in a real-world setting.

Combining TAS-102 with bevacizumab resulted in significantly better disease control rates (75.9% vs. 40-50% for other combinations), PFS (6.3 months vs. 3.0 months), and OS (12.0 months vs. 6.0-6.5 months), suggesting that this combination therapy may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploration of Trifluridine/Tipiracil Monotherapy and in Combination With Bevacizumab or Immune Checkpoint Inhibitors for Patients With Metastatic Colorectal Cancer: A Real-World Study. Nie, C., Xu, W., Chen, B., et al.[2023]

Oxaliplatin is a promising treatment for colorectal cancer (CRC) that works well in combination with 5-fluorouracil (5-FU), even in cases where tumors are resistant to 5-FU, as shown in controlled phase III trials.

With its excellent safety profile and unique mechanism of action, oxaliplatin can be effectively combined with other chemotherapy agents, and ongoing studies aim to optimize its use in CRC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxaliplatin: a new therapeutic option in colorectal cancer. Cvitkovic, E., Bekradda, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8085021/

A Phase 1b Expansion Study of TAS-102 With Oxaliplatin ... The TAS-OX clinical trial evaluated the safety and effectiveness of combining two chemotherapy agents for metastatic colorectal cancer: TAS-102 and oxaliplatin.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.189

TAS102 in combination with oxaliplatin (TASOX) for ... TASOX is effective as a 3rd line therapy for patients with mCRC. In our study, overall disease control rate was 77% with up to 19 months on study.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949819825000846

Results of a phase II trial of short-course radiation and ... Myerson et al.8 reported a 70% rate of downstaging to stage ypT0-2 among 76 patients with stage II-IV rectal cancer treated with short-course radiotherapy (SC ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11272516/

Innovations in colorectal cancer treatment: trifluridine and ... The disease control rate is 59.1% with adverse effects such as leukopenia (15.9%), neutropenia (15.9%), and hypertension (40.9%). This study ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214963

Trifluridine–Tipiracil and Bevacizumab in Refractory ... Among patients with refractory metastatic colorectal cancer, treatment with FTD–TPI plus bevacizumab resulted in longer overall survival than FTD–TPI alone.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11067808/

Efficacy and Safety of Trifluridine/Tipiracil-Containing ... We performed a systematic literature review to identify and summarize data from studies reporting clinical efficacy and safety outcomes for ...