Histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Age >18 years. Life expectancy > 12 weeks ECOG performance status = 1 Participants must have normal organ and marrow function. Adequate contraception prior to study entry and for the duration of study participation. Ability to understand and the willingness to sign a written informed consent document. MedDRA version: 14.0
Conditions
Interventions
Trade Name: Xeloda
Product Name: capecitabine
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Current Sponsor code: capecitabine
Other descriptive name: cape
Conc
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. • All standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab, and panitumumab) are allowed as administered therapy before study entry. No more than two lines of treatment for metastatic or recurrent disease are allowed, except for patients with KRAS-wt tumors, for which third line with anti-EGFR agents is allowed. • Age over 18 years. • Life expectancy of greater than 12 weeks. • ECOG performance status = 1. • Participants must have normal organ and marrow function as defined below: • Leukocytes > 3,000/mcL • Absolute neutrophil count > 1,500/mcL • Platelets > 100,000/mcL • total bilirubin within 2 × normal institutional limits • AST/ALT/PAKL levels 35mL/min • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • Ability to understand and the willingness to sign a written informed consent document. 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 89 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. • Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. • Participants may not be receiving any other study agents. • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or capecitabine. • Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months, or major surgery within four weeks. • Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. • Pregnant women are excluded from this study because sorafenib and capecitabine are antitumor agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with sorafenib or capecitabine, breastfeeding should be discontinued if the mother is treated with sorafenib or capecitabine. These potential risks may also apply to other agents used in this study. • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a) To obtain a preliminary assessment about the activity of the combination by estimating overall survival of the study population at a fixed time point (6 months) b) To compare as an exploratory analysis the overall survival of metabolic responders versus non-responders. ;Secondary Objective: • Determine the progression-free survival of the study population receiving the study regimen. • Determine the objective response rate of the study population receiving the study re-gimen, as assessed by standard imaging. • Describe the adverse reactions associated with the study regimen in the study population. • Determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regi-men, with overall survival, progression-free survival, and response rate. • Determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression under the latest prior regimen administered to the patient, with overall survival and progression-free survival. ;Primary end point(s): a) To obtain a preliminary assessment about the activity of the combination by estimating overall survival of the study population at a fixed time point (6 months) b) To compare as an exploratory analysis the overall survival of metabolic responders versus non-responders. ;Timepoint(s) of evaluation of this end point: completion of study : september 2011 6 months overal survival : march 2012 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To estimate the progression-free survival distribution of the study population • To determine the objective response rate of the study population as assessed by standard imaging. • To describe the adverse reactions associated with the study regimen in the study population. • To determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regimen, with overall survival, progression-free survival, and response. • To determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression under the latest prior regimen administered to the patient, with overall survival and progression-free survival. ;Timepoint(s) of evaluation of this end point: completion of study : september 2011 6 months overal survival : march 2012 | — |
Countries
Belgium
Contacts
Public ContactAlain Hendlisz
Institut Jules Bordet
Outcome results
None listed