Study on TAS-102 and Oxaliplatin for Treating Advanced Stage IV Colon Cancer
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT04294264
This clinical trial is exploring how well the combination of TAS-102 and oxaliplatin works in treating patients with advanced stage IV colon cancer. These chemotherapy drugs aim to stop cancer cells from growing, dividing, or spreading.
Patient Parameters
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Program Overview
This phase II study is testing the effectiveness of two chemotherapy drugs, TAS-102 and oxaliplatin, in patients with stage IV colon cancer. These drugs work by targeting cancer cells to stop their growth, division, or spread. The study aims to see how well these drugs can control the cancer and improve patient outcomes.
Description
The main goal of this study is to determine the overall response rate (ORR) of the treatment. Secondary goals include measuring how long patients live without the cancer getting worse (progression-free survival), overall survival, disease control rate, duration of response, and the safety and tolerability of the treatment.
Patients will take TAS-102 orally twice a day for five days and receive oxaliplatin through an IV over two hours on the first day. This cycle repeats every 14 days as long as the cancer does not progress and the treatment is tolerated well. After finishing the treatment, patients will have a follow-up visit 28 days later.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV colon cancer that has progressed after standard treatments, including specific chemotherapy drugs.
- Patients who had a recurrence during or shortly after completing adjuvant chemotherapy can count that as one treatment regimen.
- Recent scans must show disease progression.
- Must have measurable cancer.
- RAS mutation and mismatch repair deficiency status must be known or tissue available for testing.
- Good overall health with an ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate blood cell counts and liver function.
- Use of effective contraception if applicable.
- Women must stop nursing before joining the study.
- Ability to take oral medication.
- Willingness to follow study procedures and sign informed consent.
Exclusion Criteria
- Previous treatment with TAS-102.
- Significant nerve damage (grade 2 or higher).
- Active brain metastases needing treatment.
- Other active cancers within the last 3 years, except certain skin or non-invasive cancers.
- Pregnant or breastfeeding women.
- Current use of other investigational drugs.
- Active infection with a fever of 38°C or higher.
- Major surgery within the last 4 weeks.
- Recent anticancer therapy within 3 weeks of starting the study drug.
- Allergic reactions to similar drugs as TAS-102.
- Participation in another clinical study or investigational drug use within the last 4 weeks.
- Severe allergic reactions to oxaliplatin not controlled with medication.
- Unresolved severe side effects from previous treatments, except certain conditions like anemia or hair loss.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Trinitas Hospital and Comprehensive Cancer Center | 07202 | Elizabeth | New Jersey |
| RWJBarnabas Health - Monmouth Medical Center Southern Campus | 08701 | Lakewood | New Jersey |
| Saint Barnabas Medical Center | 07039 | Livingston | New Jersey |
| RWJBarnabas Health - Monmouth Medical Center | 07740 | Long Branch | New Jersey |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| RWJBarnabas Health - Community Medical Center | 08755 | Toms River | New Jersey |
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