Metastatic Colorectal CarcinomaPhase 2NCT04294264
TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
A Phase 2 study testing Oxaliplatin and Trifluridine and Tipiracil Hydrochloride in people with Metastatic Colorectal Carcinoma and Recurrent Colon Carcinoma, run by Rutgers, The State University of New Jersey at 6 sites in United States.
Trial summary
This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma, Recurrent Colon Carcinoma, Refractory Colorectal Carcinoma
- What is being tested?
- Oxaliplatin and Trifluridine and Tipiracil Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Feb 2019to 27 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage IV colon cancer (American Joint Committee on Cancer [AJCC] 7th edition) that has progressed after standard therapy that included fluorouracil (5-FU), irinotecan, oxaliplatin, bevacizumab (unless contraindicated) and an anti-EGFR antibody, if RAS wild type. Patients who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate
- Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen
- Progression of disease must be documented on the most recent scan
- Presence of measurable disease
- RAS mutation and mismatch repair deficiency (MMR) status must be determined (or tissue availability for testing if not already determined)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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- Life expectancy of at least 3 months
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Hemoglobin >= 9 g/dL
- Platelets (PLT) >= 75 x 10^9/L
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x upper limit of normal (ULN)
- Adequate contraception if applicable
- Women who are nursing and discontinue nursing prior to enrollment in the program
- Ability to take oral medication (i.e., no feeding tube)
- Patient able and willing to comply with study procedures as per protocol
- Patient 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
Who cannot join
- Patients who have previously received TAS-102
- Grade 2 or higher peripheral neuropathy (functional impairment)
- Symptomatic central nervous system (CNS) metastases requiring treatment
- Other active malignancy within the last 3 years (except for non-melanoma skin cancer or a non-invasive/in situ cancer)
- Pregnancy or breast feeding
- Current therapy with other investigational agents
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- Active infection with body temperature >= 38 degree Celsius (C) due to infection
- Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to drug administration)
- Any anticancer therapy within prior 3 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 4 weeks
- Grade 3 or higher hypersensitivity reaction to oxaliplatin, 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
About this study
Official title: TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer
This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Read the detailed description
PRIMARY OBJECTIVE:
- Overall response rate (ORR).
SECONDARY OBJECTIVES:
- Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V. Safety and tolerability.
OUTLINE:
Patients receive trifluridine and tipiracil hydrochloride (TAS-102) orally (PO) twice daily (BID) on days 1-5 and oxaliplatin intravenously (IV) over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
- Conditions
- Metastatic Colorectal Carcinoma, Recurrent Colon Carcinoma, Refractory Colorectal Carcinoma, Stage IV Colon Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7
- Being tested
- Oxaliplatin, Trifluridine and Tipiracil Hydrochloride
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given IV
Trifluridine and Tipiracil HydrochlorideDrug
Also called Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TAS-102, oxaliplatin) | Experimental | 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. Receives: Drug: Oxaliplatin; Drug: Trifluridine and Tipiracil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
Measured: Up to 2 years
Secondary outcomes (5)
Progression free survival
Progression will be assessed by a computed tomography CT scan according to RECIST criteria version 1.1. This criterion will be estimated by the Kaplan-Meier method. Patients who have not progressed or died at the time of analysis will be censored at the time of their latest follow-up with clinically stable disease.
Measured: From the date of start of treatment to the date of first documented progression or any cause of death during the study, assessed up to 2 years
Overall survival
Measured: Up to 2 years
Disease control rate
Measured: Up to 2 years
Duration of response
Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
Measured: Up to 2 years
Incidence of adverse events
All recorded adverse events will be listed and tabulated by system organ class and dose level. Will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 5.0 for toxicity and adverse event reporting.
Measured: Up to 28 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start12 Feb 2019
- Primary completion27 Mar 2024
- Study completion27 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Howard S. Hochster, MD, Rutgers Cancer Institute of New Jersey
- Investigators
- Howard S Hochster, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294264
- Sponsor's protocol ID
- Pro2018001469
- Other IDs
- NCI-2020-00871, Pro2018001469, 071801, P30CA072720
- Status last verified
- Nov 2024
- First submitted
- 2 Mar 2020
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04294264
- Acronym / sponsor ID
- Pro2018001469
- Conditions
- Metastatic Colorectal Carcinoma, Recurrent Colon Carcinoma, Refractory Colorectal Carcinoma, Stage IV Colon Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2026 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed description
PRIMARY OBJECTIVE:
- Overall response rate (ORR).
SECONDARY OBJECTIVES:
- Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V. Safety and tolerability.
OUTLINE:
Patients receive trifluridine and tipiracil hydrochloride (TAS-102) orally (PO) twice daily (BID) on days 1-5 and oxaliplatin intravenously (IV) over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TAS-102, oxaliplatin) | Experimental | Drug: Oxaliplatin, Drug: Trifluridine and Tipiracil HydrochloridePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed stage IV colon cancer (American Joint Committee on Cancer [AJCC] 7th edition) that has progressed after standard therapy that included fluorouracil (5-FU), irinotecan, oxaliplatin, bevacizumab (unless contraindicated) and an anti-EGFR antibody, if RAS wild type. Patients who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate
- Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen
- Progression of disease must be documented on the most recent scan
- Presence of measurable disease
- RAS mutation and mismatch repair deficiency (MMR) status must be determined (or tissue availability for testing if not already determined)
Key exclusion criteria (13 listed)
- Patients who have previously received TAS-102
- Grade 2 or higher peripheral neuropathy (functional impairment)
- Symptomatic central nervous system (CNS) metastases requiring treatment
- Other active malignancy within the last 3 years (except for non-melanoma skin cancer or a non-invasive/in situ cancer)
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven IV | Drug | Treatment (TAS-102, oxaliplatin) |
| Trifluridine and Tipiracil HydrochlorideAlso: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with TrifluridineGiven PO | Drug | Treatment (TAS-102, oxaliplatin) |
Primary outcome
Overall response rate
Time frame: Up to 2 years
Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
5 secondary outcomes
Progression free survival
Time frame: From the date of start of treatment to the date of first documented progression or any cause of death during the study, assessed up to 2 years
Overall survival
Time frame: Up to 2 years
Disease control rate
Time frame: Up to 2 years
Duration of response
Time frame: Up to 2 years
Incidence of adverse events
Time frame: Up to 28 days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard S Hochster principal investigator
Rutgers Cancer Institute of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin and Trifluridine and Tipiracil Hydrochloride in people with Metastatic Colorectal Carcinoma and Recurrent Colon Carcinoma, run by Rutgers, The State University of New Jersey at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.