Oxaliplatin for Stage IVA Colon Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage IVA Colon Cancer+5 MoreOxaliplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Colorectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVB Colon Cancer
  • Stage IV Colon Cancer
  • Refractory Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Year 2
Progression free survival
Up to 2 years
Disease control rate
Duration of response
Overall response rate
Overall survival
Day 28
Incidence of adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

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

Trial Design

1 Treatment Group

Treatment (TAS-102, oxaliplatin)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Oxaliplatin · No Placebo Group · Phase 2

Treatment (TAS-102, oxaliplatin)Experimental Group · 2 Interventions: Oxaliplatin, Trifluridine and Tipiracil Hydrochloride · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
376 Previous Clinical Trials
58,578 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,461 Total Patients Enrolled
29 Trials studying Stage IVA Colon Cancer
1,838 Patients Enrolled for Stage IVA Colon Cancer
Howard S HochsterPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Saint Barnabas Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%