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Alkylating agents
Chemotherapy + Bevacizumab for Metastatic Colorectal Cancer (SCOTI Trial)
Phase 2
Recruiting
Led By Howard S. Hochster, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death up to 100 months
Awards & highlights
Summary
This trial evaluates the effectiveness of two treatments for late-line mCRC, using a combination of oxaliplatin, irinotecan and bevacizumab.
Who is the study for?
This trial is for adults with stage IV colon cancer that's worsened after standard treatments, including chemotherapy and antibody therapy. Candidates must have normal albumin levels, measurable disease progression, acceptable organ function, and a life expectancy of at least three months. Pregnant or breastfeeding individuals, those with severe allergies to the drugs used in this study or certain medical conditions are excluded.
What is being tested?
The study tests a sequential combination treatment for metastatic colorectal cancer using TAS-102 alternated with oxaliplatin (TAS-OX) and irinotecan plus bevacizumab. It aims to assess how well the disease is controlled and how long before it progresses.
What are the potential side effects?
Potential side effects include allergic reactions to medication components, digestive issues like diarrhea if intolerant to irinotecan previously, increased risk of infection due to lowered white blood cell counts, fatigue from anemia, nerve damage symptoms like numbness or tingling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of death up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death up to 100 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease control rate (DCR)
Secondary study objectives
Duration of Response
Overall Response Rate (ORR)
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumabExperimental Treatment1 Intervention
Each treatment cycle will be fourteen days long. TAS-102 25 mg/m2 will be taken orally twice daily on days 1-5 of each cycle. Oxaliplatin 85 mg/m2 infusion will be given on day one for one cycle alternating with Irinotecan 150 mg/m2 infusion, which will be given on day one the next cycle.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,332 Total Patients Enrolled
Howard S. Hochster, MDPrincipal InvestigatorCancer Institute of New Jersey Rutgers
14 Previous Clinical Trials
272 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously taken the medication TAS-102.I need treatment for cancer that has spread to my brain and is causing symptoms.I couldn't handle irinotecan before because it caused severe diarrhea.I am 18 years old or older.I can take pills by mouth.I have side effects from previous treatments that are moderate or worse.My cancer's RAS mutation and MMR status are known or can be tested.I have severe nerve damage in my hands or feet.I currently have a fever over 38°C due to an infection.I have not had major surgery in the last 4 weeks.I've had a severe allergic reaction to oxaliplatin or irinotecan.My stage IV colon cancer has worsened despite treatment with standard therapies.My cancer can be measured by tests.I am fully active or can carry out light work.I haven't had any cancer except for non-melanoma skin cancer or non-invasive cancer in the last 3 years.My organs are functioning well.I haven't had cancer treatment in the last 2 weeks.My cancer returned within 6 months after finishing chemotherapy.I had to stop standard treatment due to severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab
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.
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