Clinical Trial in Patients With Metastatic Colorectal Cancer

NCT00235898 | Completed Phase 2 DMC

• 1 other identifier: 03-CoFactor
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 30

Brief 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.

Conditions

Colon Cancer; Rectal Cancer

Study Arms (2)

1

EXPERIMENTAL

CoFactor, 5-FU

Drug: CoFactor; Drug: 5-FU

2

ACTIVE COMPARATOR

Leucovorin, 5-FU

Drug: 5-FU; Drug: Leucovorin

Interventions

CoFactor DRUG

Also known as: ANX-510

1

5-FU DRUG

Also known as: 5-Fluorouracil

1; 2

Leucovorin DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have recovered from any toxicities resulting from prior therapies (except for alopecia).
• Adequate renal, bone marrow, liver function defined as serum creatinine less than 1.5 times the upper limit of normal, serum bilirubin less than 2 times the upper limit of normal, ANC greater than 1.5 x 109/L, Platelet count greater than 90 x 109/L, SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead

Study Sites (30)

Global Hospital

Hyderabad, Andhra Pradesh, 500 004, India

Location

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

Hyderabad, Andhra Pradesh, 560 082, India

Location

Kasturba Medical College

Mangalore, Attavar, 575001, India

Location

Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre

Pune, Erandawane, 411004, India

Location

Department of Medical Oncology, Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

Location

Department of Oncology, Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Manipal Hospital

Bangalore, 560017, India

Location

SMS Medical College Hospital

Jaipur, 302004, India

Location

Department of Medical Oncology, Dayanad Medical College and Hospital

Ludhiana, 141001, India

Location

Department of Medical Oncology, Jaslok Hospital and Research Centre

Mumbai, 400 026, India

Location

Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie

Roentgena, Warszawa, Poland

Location

Department and Clinic for Oncology and Radiotherapy

Gdansk, 80-211, Poland

Location

Department for Oncology and Radiotherapy, Szpital Morski im. PCK

Gdynia Redlowo, Poland

Location

Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny

Lodz, 93-509, Poland

Location

Oncological Chemotherapy Department Centrum Onkologii Ziemi

Lublin, 20-090, Poland

Location

Clinical Oncology Department, Wojewodski Szpital Zespolony

Torun, 87-100, Poland

Location

Gastroenterology and Hepatology Department, Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II

Bucharest, Romania

Location

Department of Medical Oncology and Radiotherapy II

Cluj-Napoca, 400015, Romania

Location

Medical Oncology Department, County Hospital Sibiu

Sibiu, 550245, Romania

Location

Clinical Center of Serbia

Belgrade, 11 000, Serbia

Location

Institute of Oncology and Radiology Serbia

Belgrade, 11 000, Serbia

Location

CHC Bezanijska

Belgrade, Serbia

Location

Clinic for Internal Medicine, Institute for Oncology Sremska

Kamenitz, 21104, Serbia

Location

CHC Kragujevac

Kragujevac, 34000, Serbia

Location

Clinic Centre Nis

Niš, 21104, Serbia

Location

General Hospital Djordje Joanovic

Zrenjanin, 23000, Serbia

Location

Haematology/Lung/GI Cancer Services

Harlow, Essex, CM20 1QX, United Kingdom

Location

Oncology Research, North Middlesex University Hospital

Middlesex, London, N18 1QX, United Kingdom

Location

Beatson Oncology Centre

Glasgow, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

5,11-methenyltetrahydrohomofolate; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• James Cassidy, MD

  Beatson Oncology Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Last Updated: August 25, 2008

Record last verified: 2008-08

Locations

GB (3); RO (4); IN (10); SE (7); PL (6)