This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. 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
153
100 mg, PO, once per day
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Unnamed facility
Alcoy, Alicante, Spain
Unnamed facility
Elche, Alicante, Spain
Number of Participants Who Died During the Study
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Overall Survival (OS) During the Study
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Number of Participants Who Died at 6 Months
Time frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
OS At 6 Months
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
Number of Participants Who Died During the Study By Rash Grade
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
OS By Rash Grade
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Number of Participants With Disease Progression or Death
Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.
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Unnamed facility
Palma de Mallorca, Balearic Islands, Spain
Unnamed facility
Barcelona, Barcelona, Spain
Unnamed facility
Barcelona, Barcelona, Spain
Unnamed facility
Barcelona, Barcelona, Spain
Unnamed facility
Barcelona, Barcelona, Spain
Unnamed facility
Manresa, Barcelona, Spain
Unnamed facility
Sabadell, Barcelona, Barcelona, Spain
Unnamed facility
Santander, Cantabria, Spain
...and 19 more locations
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
PFS
The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Percentage of Participants With Disease Control According to RECIST
Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.