Metastatic Colorectal Carcinoma MedDRA version: 7.1 Level: PT Classification code 10052358
Conditions
Interventions
Product Name: CoFactor
Pharmaceutical Form: Powder for infusion*
CAS Number: 3432-99-3
Current Sponsor code: CoFactor
Other descriptive
(d,l)-5,10-methylenetetrahydrofolic acid calcium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
ADVENTRX Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or a non-pregnant, non-lactating female subjects. = 18 years of age. Surgically incurable, confirmed metastatic colon or rectal adenocarcinoma. Have measurable disease for response assessment. At least one measurable lesion with a diameter = 20 mm using conventional CT or MRI scans or = 10 mm using spiral CT scans (use of spiral must be documented in medical records and used consistently throughout the study). Ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but be present if measurable disease is present for evaluation. Have a ECOG Performance level of 1-2 (or Karnofsky 100-70). A lower ECOG Performance level is acceptable only if clearly due to non-oncologic problems (e.g., prior paraplegia from polio). Have a life expectancy of a least 6 months. Have recovered from any toxicities resulting from prior therapies (patients with alopecia will not be excluded). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion 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. Concurrent infection including diagnoses of FUO and evidence of possible central line sepsis (subject must be afebrile at the start of therapy). Unstable oncologic emergency syndromes superior vena cava (SVC) syndromes, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc. Unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc. Cerebellar neurologic syndromes such as Parkinson’s disease, multiple sclerosis, and amyotonia. Have received prior chemotherapy for established metastatic disease. A known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase) deficiency. Less than 8-weeks since radiation therapy or less than 4 weeks since major surgery. Less than 6 months since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy. Patients with vomiting, diarrhea, nausea of Grade greater than 1. Females of childbearing potential who do not agree to use adequate contraception throughout their participation in this study and for 30 days after discontinuation of study medication. (Women of childbearing potential must have a negative pregnancy test prior to the start of the study.) Have laboratory results of – Serum creatinine greater than 1.5 times the upper limit of normal Serum bilirubin greater than 2 times the upper limit of normal ANC <1.5 x 10*9/L Platelet count <90 x 10*9/L SGOT (AST) and SGPT (ALT) greater than 3 times the upper limit of normal. Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: The primary end-point for this study is defined as a lower incidence of Grade 3 or greater toxicities (as defined by the NCI Common Terminology Criteria for Adverse Events version 3.0) in Treatment Arm A compared to Treatment Arm B.; Secondary Objective: Secondary objective: Response rate (partial and complete); Time to progression; Quality of life. ; Primary end point(s): Primary Objective The primary end-point for this study is defined as a lower incidence of Grade 3 or greater toxicities (as defined by the NCI Common Terminology Criteria for Adverse Events version 3.0) in Treatment Arm A compared to Treatment Arm B. ` | — |
Countries
United Kingdom
Outcome results
None listed