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Anti-metabolites
CoFactor + Avastin for Colorectal Cancer
Phase 3
Waitlist Available
Research Sponsored by Mast Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgically incurable, metastatic disease from proven colon or rectal adenocarcinoma
ECOG Performance Status is 0-2 or Karnofsky performance level of 100-70
Must not have
Inadequate bone marrow, liver or kidney function defined as: Serum creatinine more than 1.5 times the upper limit of normal, Urine protein to creatinine ratio >1, Serum bilirubin > 2 times the upper limit of normal, ANC < 1.5 x 109/L, Hemoglobin < 9.0 g / dL, Platelet count < 90 x 109/L, SGOT (AST) and SGPT (ALT) more than 3 times the upper limit of normal, or more than 5 times the upper limit of normal for subjects with documented liver metastases
Presence of serious non-healing wounds, gastro-duodenal ulcers active by endoscopy, gastro-intestinal perforation or intra-abdominal abscess, skin ulcers, or bone fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether a different drug given with 5-FU will help people with metastatic colorectal cancer live longer without their disease getting worse.
Who is the study for?
This trial is for adults over 18 with metastatic colorectal cancer that can't be removed by surgery. They must have measurable disease, no prior systemic chemotherapy for advanced disease, and a life expectancy of at least 3 months. Pregnant or breastfeeding women, those not using contraception if of child-bearing potential, and individuals with certain health conditions like uncontrolled heart disease or inadequate organ function are excluded.
What is being tested?
The study compares two treatments to see which one keeps the cancer from getting worse longer. One group receives a combination of the drugs CoFactor and Avastin along with the chemotherapy drug 5-FU; another group gets Leucovorin (LV) instead of CoFactor with Avastin and 5-FU.
What are the potential side effects?
Possible side effects include reactions to medication infusions, increased risk of bleeding or blood clots due to Avastin, diarrhea from 5-FU, fatigue, lowered immunity leading to infections, liver issues from elevated enzymes levels in blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My colon or rectal cancer has spread and cannot be removed with surgery.
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I can take care of myself but may not be able to do heavy physical work.
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I am 18 years old or older.
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I have a tumor that can be measured by scans.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious non-healing wounds or ulcers.
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I do not have serious heart or blood vessel problems.
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I do not have an ongoing infection and am fever-free.
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I haven't had major surgery or a serious injury in the last 4 weeks and don't expect to need major surgery during the study.
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I am not taking sorivudine, Brivudin, or similar drugs.
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I am allergic or have had a bad reaction to certain chemotherapy drugs.
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I have been treated with bevacizumab before.
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I do not have any urgent cancer-related complications like severe swelling, jaundice needing a stent, spinal issues, or uncontrolled bleeding.
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I have had brain metastasis, a brain tumor, or a stroke.
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I haven't had a heart attack, stroke, or similar event in the last year.
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I have an organ transplant and am on immunosuppressive drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment3 Interventions
CoFactor, 5-FU, Avastin
Group II: 2Active Control3 Interventions
Leucovorin, 5-FU, Avastin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Find a Location
Who is running the clinical trial?
Mast Therapeutics, Inc.Lead Sponsor
14 Previous Clinical Trials
1,285 Total Patients Enrolled
M. Wasif Saif, MD, MBBSStudy ChairYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemo or immunotherapy for my advanced cancer, but may have had specific drugs with radiotherapy over 6 months ago.My colon or rectal cancer has spread and cannot be removed with surgery.I can take care of myself but may not be able to do heavy physical work.I have serious non-healing wounds or ulcers.My INR is above 1.5, but it's controlled between 2-3 with a stable dose of anticoagulants.I haven't had radiation therapy in the last 6 weeks or on the cancer spots chosen for this study unless they've gotten worse.I do not have serious heart or blood vessel problems.I am 18 years old or older.My cancer has spread and this was confirmed by tests or allowed exceptions.I finished my previous cancer treatment over 6 months ago, which may have included oxaliplatin and irinotecan.I do not have an ongoing infection and am fever-free.I haven't had major surgery or a serious injury in the last 4 weeks and don't expect to need major surgery during the study.You are expected to live for at least 3 more months.I am not taking sorivudine, Brivudin, or similar drugs.I have a tumor that can be measured by scans.I am allergic or have had a bad reaction to certain chemotherapy drugs.I have been treated with bevacizumab before.I do not have any urgent cancer-related complications like severe swelling, jaundice needing a stent, spinal issues, or uncontrolled bleeding.I have had brain metastasis, a brain tumor, or a stroke.I haven't had a fine needle aspiration or a central line placed in the last week.I have no known allergies to leucovorin or similar drugs.I haven't had a heart attack, stroke, or similar event in the last year.I have an organ transplant and am on immunosuppressive drugs.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.