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Alkylating agents

Resected or metastatic CRC for Colorectal Cancer

N/A
Waitlist Available
Led By SANJAY GOEL, M.D.
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change over 1 treatment cycle, up to 4 weeks
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This study is for patients with advanced or stage II and III colon or rectal cancer. The primary purpose of this research study is to determine if a particular protein in the patient's blood will change when they receive treatment with a drug called oxaliplatin, which is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought that the amount of this protein in the blood could influence the manner in which the patient responds to oxaliplatin.

Eligible Conditions
  • Colorectal Cancer
  • Colon Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change over 1 treatment cycle, up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change over 1 treatment cycle, up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin

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%
Cough
10%
Dyspnoea
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Depression
9%
Dysphonia
9%
Pyrexia
8%
Anxiety
8%
Fall
8%
Proteinuria
8%
Dry skin
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%
Hypoalbuminaemia
5%
Nail disorder
5%
Intestinal obstruction
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Bronchitis
2%
Gastroenteritis
2%
Pneumonia
2%
Lower respiratory tract infection
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%
Procedural site reaction
1%
Gastrointestinal perforation
1%
Wound infection
1%
Gastroenteritis viral
1%
Infected dermal cyst
1%
Pneumonia streptococcal
1%
Lobar pneumonia
1%
Inguinal hernia
1%
Muscle abscess
1%
Clostridium difficile colitis
1%
Intestinal perforation
1%
Infusion related reaction
1%
Pharyngitis
1%
Infective exacerbation of chronic obstructive airways disease
1%
Anal fissure
1%
Colitis
1%
Ileus
1%
Colonic obstruction
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Resected or metastatic CRCExperimental Treatment1 Intervention
All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor
2,205 Previous Clinical Trials
4,037,014 Total Patients Enrolled
Albert Einstein College of MedicineLead Sponsor
296 Previous Clinical Trials
11,688,953 Total Patients Enrolled
SANJAY GOEL, M.D.Principal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine
~4 spots leftby Nov 2025
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