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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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 belowSelect...
My stage IV colon cancer has worsened after standard treatment.
Select...
I am fully active or can carry out light work.
Select...
My cancer can be measured by tests or scans.
Select...
My cancer's RAS mutation and MMR status are known or can be tested.
Select...
I can swallow pills on my own without a feeding tube.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreSide effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
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%
Insomnia
20%
Paraesthesia
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
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Anxiety
8%
Dry skin
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
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%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
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%
Intestinal perforation
1%
Infective exacerbation of chronic obstructive airways disease
1%
Inguinal hernia
1%
Colitis
1%
Colonic obstruction
1%
Muscle abscess
1%
Infected dermal cyst
1%
Gastroenteritis viral
1%
Gastrointestinal perforation
1%
Clostridium difficile colitis
1%
Ileus
1%
Anal fissure
1%
Lobar pneumonia
1%
Pharyngitis
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
13,654 Previous Clinical Trials
40,933,103 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,182 Total Patients Enrolled
Howard S HochsterPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My stage IV colon cancer has worsened after standard treatment.I haven't had cancer treatment in the last 3 weeks.I stopped my cancer treatment due to severe side effects.You have had allergic reactions to similar medications like TAS-102 in the past.I had a severe allergic reaction to oxaliplatin.I am not currently in another clinical study or haven't taken any experimental drugs in the last 4 weeks.I am fully active or can carry out light work.I have not had major surgery in the last 4 weeks.My cancer can be measured by tests or scans.My cancer's RAS mutation and MMR status are known or can be tested.My cancer returned within 6 months after finishing chemotherapy.I currently have an infection with a fever of 38°C or higher.You are currently taking other experimental medications for treatment.I can swallow pills on my own without a feeding tube.I have previously been treated with TAS-102.I need treatment for cancer that has spread to my brain and is causing symptoms.I have moderate to severe numbness, tingling, or pain in my hands or feet.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.I have not had any cancer except for non-melanoma skin cancer or a non-invasive cancer in the last 3 years.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TAS-102, oxaliplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enlisted in this clinical experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this study commenced recruitment activities on February 12th 2019 and is presently accepting 50 patients from 6 different medical centres."
Answered by AI
Are there still opportunities to join this clinical exploration?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this research endeavour, which was introduced to the public on February 12th 2019, is still open for recruitment. Approximately 50 volunteers must be sourced from 6 distinct medical centres across the nation."
Answered by AI
What is the geographic scope of this research initiative?
"Currently, 6 medical centres are recruiting participants for this trial. These include Toms River, Long Branch and Elizabeth alongside 3 other cities. To minimize travel needs, it is wise to select the closest clinic available if you choose to join the study."
Answered by AI
What pathologies does Oxaliplatin typically help ameliorate?
"Oxaliplatin is usually employed to combat diseases that have been previously treated with oxaliplatin chemotherapy. It may also be beneficial in treatment of stage III colon cancer, metastatic colorectal cancer (CRC), and any other illnesses which had prior anti-VEGF therapy."
Answered by AI
Are there any other past or present experiments involving Oxaliplatin?
"At the moment, 377 clinical trials for Oxaliplatin are in progress with 126 of those being Phase 3. While Woolloongabba, Queensland is a primary location for these studies, there are 14178 total sites involved with researching this medication."
Answered by AI
How hazardous is Oxaliplatin to human health?
"Due to the fact that Oxaliplatin has only gone through Phase 2 trials, it was given a safety score of two. This indicates there is some data suggesting its security, but no evidence yet demonstrating its efficacy."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Saint Barnabas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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