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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Duration of response

Incidence of adverse events

Progression free survival

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%

Paraesthesia

20%

Insomnia

20%

Alopecia

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%

Cough

10%

Dyspnoea

10%

Abdominal pain upper

10%

Dyspepsia

10%

Pulmonary embolism

10%

Dizziness

Depression

Dysphonia

Pyrexia

Dry skin

Anxiety

Proteinuria

Fall

Lethargy

Abdominal distension

Rectal haemorrhage

Toothache

Neck pain

Rhinorrhoea

Dehydration

Oropharyngeal pain

Non-cardiac chest pain

Hypoalbuminaemia

Nail disorder

Intestinal obstruction

Hypotension

Haemorrhoids

Oral candidiasis

Oral herpes

Hypokalaemia

Muscle spasms

Sepsis

Lower respiratory tract infection

Gastroenteritis

Pneumonia

Bronchitis

Small intestinal obstruction

Anal abscess

Flank pain

Renal failure acute

Confusional state

Febrile neutropenia

Angina pectoris

Enterovesical fistula

Infusion related reaction

Gastrointestinal perforation

Infected dermal cyst

Wound infection

Gastroenteritis viral

Procedural site reaction

Clostridium difficile colitis

Pneumonia streptococcal

Intestinal perforation

Inguinal hernia

Lobar pneumonia

Muscle abscess

Pharyngitis

Infective exacerbation of chronic obstructive airways disease

Anal fissure

Colitis

Ileus

Colonic obstruction

Large intestine perforation

Melaena

Neutropenic colitis

Cholecystitis acute

Urosepsis

Cerebrovascular accident

Hemiparesis

Syncope

Rectal perforation

Catheter site pain

Extravasation

Abscess limb

Radius fracture

Hypomagnesaemia

Hypophagia

Haematuria

Hydronephrosis

Urinary incontinence

Pleural effusion

Pleuritic pain

Musculoskeletal chest pain

Procedural pain

Laceration

Gastrointestinal haemorrhage

Large intestinal obstruction

Transient ischaemic attack

Acute psychosis

Pneumonia aspiration

Jugular vein thrombosis

Orthostatic hypotension

Thrombophlebitis superficial

Device related infection

Ear infection

Enterocolitis infectious

Eyelid infection

Gangrene

Pilonidal cyst

Gastritis

Visual impairment

Dysphagia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab: Phase A and Phase B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2890

Trifluridine and Tipiracil Hydrochloride

2019

Completed Phase 2

~180