This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
80 mg/m2/day, intravenous (IV), every 3 weeks
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
50 mg/m2/day, IV, every 3 weeks
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
Time frame: Approximately 3.25 years
Overall Response Rate (ORR)
ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.
Time frame: Approximately 3.25 years
Progression-Free Survival (PFS)
PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Approximately 3.25 years
Overall Survival (OS)
OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.
Time frame: Approximately 3.25 years
Duration of Response
Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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60 mg/m2/day, IV, every 3 weeks
625 mg/m2, oral, twice daily per 3-week cycle
130 mg/m2/day, IV, every 3 weeks
60 mg/m2/day, IV, every 3 weeks
825 mg/m2, oral, twice daily for 2 weeks
Unnamed facility
Alcoy, Alicante, Spain
Unnamed facility
Ávila, Avila, Spain
Unnamed facility
Palma de Mallorca, Balearic Islands, Spain
Unnamed facility
Palma de Mallorca, Balearic Islands, Spain
Unnamed facility
Barcelona, Barcelona, Spain
Unnamed facility
Burgos, Burgos, Spain
Unnamed facility
Cadiz, Cadiz, Spain
Unnamed facility
Jerez de la Frontera, Cadiz, Spain
Unnamed facility
Puerto Real, Cadiz, Spain
Unnamed facility
Castellon, Castellon, Spain
...and 41 more locations
Time frame: Approximately 3.25 years
Time to Response
Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.
Time frame: Approximately 3.25 years