Clinical trial NCT00235898: Clinical Trial in Patients With Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Rectal Cancer
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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