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Alkylating agents

TAS-102 + Oxaliplatin for Colon Cancer

Phase 2
Waitlist Available
Led By Howard S Hochster
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy
ECOG performance status 0-1
Must not have
Any anticancer therapy within prior 3 weeks of first dose of study drug
Grade 3 or higher hypersensitivity reaction to oxaliplatin, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial studies TAS-102 and oxaliplatin to see how well they work in treating patients with stage IV colon cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
TAS-102 and oxaliplatin may cause side effects like fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling in hands and feet (neuropathy), allergic reactions, liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My stage IV colon cancer has worsened after standard treatment.
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I am fully active or can carry out light work.
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My cancer can be measured by tests or scans.
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My cancer's RAS mutation and MMR status are known or can be tested.
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I can swallow pills on my own without a feeding tube.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatment in the last 3 weeks.
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I had a severe allergic reaction to oxaliplatin.
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I have not had major surgery in the last 4 weeks.
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I currently have an infection with a fever of 38°C or higher.
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I have previously been treated with TAS-102.
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I need treatment for cancer that has spread to my brain and is causing symptoms.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have side effects from previous treatments that are still bothering me, except for anemia, hair loss, skin color changes, or nerve damage from platinum-based therapy.
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I have not had any cancer except for non-melanoma skin cancer or a non-invasive cancer in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Disease control rate
Duration of response
Incidence of adverse events
+2 more

Side effects data

From 2016 Phase 4 trial • 128 Patients • NCT01588990
68%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Alopecia
20%
Paraesthesia
20%
Insomnia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Depression
9%
Dysphonia
9%
Pyrexia
8%
Dry skin
8%
Anxiety
8%
Proteinuria
8%
Fall
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Rhinorrhoea
6%
Oropharyngeal pain
6%
Dehydration
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Bronchitis
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Colitis
1%
Clostridium difficile colitis
1%
Intestinal perforation
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Inguinal hernia
1%
Anal fissure
1%
Colonic obstruction
1%
Ileus
1%
Infected dermal cyst
1%
Muscle abscess
1%
Pharyngitis
1%
Infective exacerbation of chronic obstructive airways disease
1%
Gastrointestinal perforation
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (TAS-102, oxaliplatin)Experimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,351 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
435 Previous Clinical Trials
64,973 Total Patients Enrolled
Howard S HochsterPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

Oxaliplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04294264 — Phase 2
Colorectal Cancer Research Study Groups: Treatment (TAS-102, oxaliplatin)
Colorectal Cancer Clinical Trial 2023: Oxaliplatin Highlights & Side Effects. Trial Name: NCT04294264 — Phase 2
Oxaliplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294264 — Phase 2
~8 spots leftby Jul 2025