Statement: the primary trial measured the Number of Participants With Disease Progression (PD) or Death, to evaluate the performance of its interventions.
Primary_evidence: Outcome Measurement:    Tumor Response   Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.   Time frame: baseline to measured progressive disease Results 1:    Arm/Group Title: Dose Level 1   Arm/Group Description: Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.   Overall Number of Participants Analyzed: 6   Measure Type: Number   Unit of Measure: participants  Complete Response: 0   Partial Response: 0   Long Stable Disease: 1   Stable Disease: 1   Progressive Disease: 2 Not Evaluable: 2 Results 2:    Arm/Group Title: Dose Level 2   Arm/Group Description: Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.   Overall Number of Participants Analyzed: 62   Measure Type: Number   Unit of Measure: participants  Complete Response: 1   Partial Response: 4   Long Stable Disease: 4   Stable Disease: 16   Progressive Disease: 32 Not Evaluable: 5