None listed
Conditions
Interventions
Trade Name: Xeloda
Product Name: Xeloda
Product Code: RO 09-1978
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration number: 150
Sponsors
Hoffmann-La Roche Inc
Roche Polska, Sp.z.o
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *) Male or female outpatients aged >= 18 years. *) Be ambulatory and have a ECOG performance status of 20 mm using conventional CT or MRI scans or >10 mm using spiral CT scans (use of spiral CT must be documented in medical records. *) Have a life expectancy of at least 3 months. 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: *) Received more than one prior chemotherapeutic or other systemic anti-cancer treatment regimen in the metastatic setting. *) Prior active or passive immunotherapy for metastatic disease, unless in combination with first line CPT-11 + 5-FU/LV. *) Prior treatment with oxaliplatin. *) Pregnant or lactating women. *) Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. *) Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. *) History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. *) History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizure not controlled with standard medical therapy, any brain metastases, or history of stroke). *) History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake. *) Clinically significant (i.e. active) cardiovascular disease e.g. uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular. In addition patients with myocardial infarction within 1 year prior to study treatment start will be excluded (see appendix 10). *) Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. *) Interstitial pneumonia or extensive symptomatic fibrosis of the lungs. *) Known peripheral neuropathy ? NCI CTC grade 1. Absence of deep tendon reflexes (DTRs) as the sole neurologic abnormality does not render the patient ineligible. *) Organ allografts requiring immunosuppressive therapy. *) Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease. *) Moderate or severe renal impairment [creatinine clearance equal to or below 50 mL/min (calculated according to Cockroft and Gault, Appendix 3)], or serum creatinine > 1.5 x upper limit of normal (ULN). *) Any of the following laboratory values: • Absolute neutrophil count (ANC) 1.5 x ULN • ALAT, ASAT > 2.5 x ULN, or > 5 x (ULN) in case of liver metastases *) Alkaline phosphatase > 2.5 x ULN, or > 5 x ULN in case of liver metastases, or > 10 x ULN in case of bone metastases. *) Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency. *) Known hypersensitivity to platinum compounds or any of the components of the study medications. *) Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the combination of capecitabine plus oxaliplatin ("XELOX") is at least equivalent to the combination of 5-fluorouracil plus leucovorin plus oxaliplatin ("FOLFOX-4”) in terms of time to tumor progression or death (TTP) in patients with metastatic colorectal carcinoma who have received prior treatment with CPT-11 in combination with 5-FU as first line therapy.;Secondary Objective: • To evaluate and compare the efficacy (overall survival, overall response rate according to the RECIST criteria, time to response, duration of response, and time to treatment failure) in the two treatment groups. • To evaluate and compare the safety profiles of the treatment groups using the NCI CTCAE (version 3.0). • To evaluate and compare perceived treatment convenience and satisfaction with treatment for patients in the two treatment groups. • To evaluate and compare medical care utilization in the two treatment groups. • To offer patients participating in the study the possibility to also participate in the independent sub-study NO16967RG designed to derive pharmacogenetic information to facilitate research regarding prediction of response to specific drug therapy, susceptibility to develop adverse effects or progress to more severe disease, or identify genetic risk factors for disease. ;Primary end point(s): At least equivalence with respect time to tumor progression or death (TTP). | — |
Countries
Slovakia
Outcome results
None listed