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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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

0 / 16Eligibility criteria met

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

5-Fluorouracil (5-FU) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00337389 — Phase 3

Colorectal Cancer Research Study Groups: 1, 2

Colorectal Cancer Clinical Trial 2023: 5-Fluorouracil (5-FU) Highlights & Side Effects. Trial Name: NCT00337389 — Phase 3

5-Fluorouracil (5-FU) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00337389 — Phase 3

~62 spots leftby Sep 2025

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