Clinical Trial in Patients With Metastatic Colorectal Cancer
Information source: Adventrx Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colon Cancer; Rectal Cancer
Intervention: CoFactor (Drug); 5-FU (Drug); Leucovorin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Adventrx Pharmaceuticals Official(s) and/or principal investigator(s):
James Cassidy, MD, Principal Investigator, Affiliation: Beatson Oncology Centre
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Department of Medical Oncology, Dayanad Medical College and Hospital, Ludhiana 141001, India
SMS Medical College Hospital, Jaipur 302004, India
Department of Medical Oncology, Jaslok Hospital and Research Centre, Mumbai 400 026, India
Manipal Hospital, Bangalore 560017, India
Department and Clinic for Oncology and Radiotherapy, Gdansk 80-211, Poland
Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny, Lodz 93-509, Poland
Department for Oncology and Radiotherapy, Szpital Morski im. PCK, Gdynia Redlowo, Poland
Oncological Chemotherapy Department Centrum Onkologii Ziemi, Lublin 20-090, Poland
Clinical Oncology Department, Wojewodski Szpital Zespolony, Torun 87-100, Poland
Department of Medical Oncology and Radiotherapy II, Cluj-Napoca 400015, Romania
Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II, Bucharest, Romania
Gastroenterology and Hepatology Department, Fundeni Clinical Institute, Bucharest 022328, Romania
Medical Oncology Department, County Hospital Sibiu, Sibiu 550245, Romania
Clinical Center of Serbia, Belgrade 11 000, Serbia and Montenegro
Institute of Oncology and Radiology Serbia, Belgrade 11 000, Serbia and Montenegro
CHC Bezanijska, Belgrade, Serbia and Montenegro
General Hospital Djordje Joanovic, Zrenjanin 23000, Serbia and Montenegro
CHC Kragujevac, Kragujevac 34000, Serbia and Montenegro
Clinic for Internal Medicine, Institute for Oncology Sremska, Sremska Kamenica 21104, Serbia and Montenegro
Clinic Centre Nis, Nis 21104, Serbia and Montenegro
Beatson Oncology Centre, Glasgow G11 6NT, United Kingdom
Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, Andhra Pradesh 560 082, India
Global Hospital, Hyderabad, Andhra Pradesh 500 004, India
Kasturba Medical College, Mangalore, Attavar 575001, India
Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre, Pune, Erandawane 411004, India
Haematology/Lung/GI Cancer Services, Harlow, Essex CM20 1QX, United Kingdom
Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, Karnataka 560029, India
Oncology Research, North Middlesex University Hospital, Middlesex, London N18 1QX, United Kingdom
Department of Oncology, Christian Medical College, Vellore, Tamil Nadu 632004, India
Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie, Roentgena, Warszawa, Poland
Additional Information
Sponsor website
Starting date: May 2005
Last updated: April 22, 2008
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