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Clinical Trial in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Clinical Trial in Patients With Metastatic Colorectal Cancer

A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU Versus Leucovorin and 5-FU in Subjects With Metastatic Colorectal Carcinoma

NCT00235898•Mast Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
•Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age.
•If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication.
•If, female of childbearing potential, have a negative pregnancy test prior to the start of the study.
•Have a life expectancy of at least 6 months.
•Have radiologically or clinically measurable disease for response assessment. Presence of ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but may be present if dimensional or other discrete measurable disease is present for evaluation.
•Have an ECOG Performance Level of 0-2 (or Karnofsky of 100-70). A lower ECOG or Karnofsky is acceptable only if clearly due to non-oncologic conditions (e.g., prior paraplegia from polio).
•Have had no prior chemotherapy for established, metastatic disease. (Subjects may have received adjuvant chemotherapy with fluoropyrimidine therapy).
•Have at least 6 months elapsed since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy.
•Have had at least an 8 week interval since any prior radiation therapy or 4 weeks since any major surgery.
+2 more criteria

Exclusion Criteria

•Failure by the subject or the subject's legal representative to sign the Informed Consent.
•An inability to obtain Informed Consent because of psychiatric or complex medical problems.
•Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
•Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc.
•Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc.
•Have cerebellar neurologic syndromes such as Parkinson's disease, multiple sclerosis, and amyotonia.
•Have a known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase deficiency).
•Patients with vomiting, diarrhea, or nausea of grade greater than 1.
•Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.

Locations (30)

Global Hospital

Hyderabad, Andhra Pradesh, India

Department of Medical Oncology, Nizam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

Kasturba Medical College

Mangalore, Attavar, India

Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre

Pune, Erandawane, India

Department of Medical Oncology, Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, India

Department of Oncology, Christian Medical College

Vellore, Tamil Nadu, India

Manipal Hospital

Bangalore, India

SMS Medical College Hospital

Jaipur, India

Department of Medical Oncology, Dayanad Medical College and Hospital

Ludhiana, India

Department of Medical Oncology, Jaslok Hospital and Research Centre

Mumbai, India

Key Dates

Start Date

May 1, 2005

Primary Completion Date

March 1, 2008

Last Updated

August 25, 2008

Enrollment

300

ACTUAL participants

Conditions

Colon CancerRectal Cancer

Interventions

CoFactor

DRUG

5-FU

DRUG

Leucovorin

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Trial in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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