Clinical Trial in Patients With Metastatic Colorectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235898
• Other study ID #: 03-CoFactor
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2005
• Last updated: August 22, 2008
• Start date: May 2005

Study information

• Verified date: August 2008
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyRomania: Ministry of Public HealthPoland: Ministry of HealthIndia: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer

Intervention

Drug:
• CoFactor

• 5-FU

• Leucovorin

Locations

Country	Name	City	State
India	Department of Medical Oncology, Kidwai Memorial Institute of Oncology	Bangalore	Karnataka
India	Manipal Hospital	Bangalore
India	Department of Medical Oncology, Nizam's Institute of Medical Sciences	Hyderabad	Andhra Pradesh
India	Global Hospital	Hyderabad	Andhra Pradesh
India	SMS Medical College Hospital	Jaipur
India	Department of Medical Oncology, Dayanad Medical College and Hospital	Ludhiana
India	Kasturba Medical College	Mangalore	Attavar
India	Department of Medical Oncology, Jaslok Hospital and Research Centre	Mumbai
India	Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre	Pune	Erandawane
India	Department of Oncology, Christian Medical College	Vellore	Tamil Nadu
Poland	Department and Clinic for Oncology and Radiotherapy	Gdansk
Poland	Department for Oncology and Radiotherapy, Szpital Morski im. PCK	Gdynia Redlowo
Poland	Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny	Lodz
Poland	Oncological Chemotherapy Department Centrum Onkologii Ziemi	Lublin
Poland	Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie	Roentgena	Warszawa
Poland	Clinical Oncology Department, Wojewodski Szpital Zespolony	Torun
Romania	Gastroenterology and Hepatology Department, Fundeni Clinical Institute	Bucharest
Romania	Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II	Bucharest
Romania	Department of Medical Oncology and Radiotherapy II	Cluj-Napoca
Romania	Medical Oncology Department, County Hospital Sibiu	Sibiu
Serbia	CHC Bezanijska	Belgrade
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Institute of Oncology and Radiology Serbia	Belgrade
Serbia	CHC Kragujevac	Kragujevac
Serbia	Clinic Centre Nis	Nis
Serbia	Clinic for Internal Medicine, Institute for Oncology Sremska	Sremska Kamenica
Serbia	General Hospital Djordje Joanovic	Zrenjanin
United Kingdom	Beatson Oncology Centre	Glasgow
United Kingdom	Haematology/Lung/GI Cancer Services	Harlow	Essex
United Kingdom	Oncology Research, North Middlesex University Hospital	Middlesex	London

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Countries where clinical trial is conducted

India,  Poland,  Romania,  Serbia,  United Kingdom, 

External Links

•   Sponsor website