Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
|Pancreatic Cancer||Drug: Mirtazapine plus gemcitabine Drug: Gemcitabine, placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Supportive Care
|Official Title:||A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer|
- quality of life [ Time Frame: up to 3 years ]primary outcome is the quality of life evaluated by SF-36 scale
- anxiety and depression scores [ Time Frame: up to 3 years ]The second outcomes include anxious and depression scores
- objective response rate [ Time Frame: up to 3 years ]
- progress free survival, [ Time Frame: up to 3 years ]
- overall Survival [ Time Frame: up to 3 years ]
- chemotherapy induced nausea and vomiting [ Time Frame: up to 3 years ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo plus gemcitabine
we design placebo plus gemcitabine as control arm
Drug: Gemcitabine, placebo
Gemcitabine 1.0g/m2,d1,d8,q3w placebo
Experimental: Mirtazapine plus gemcitabine
We design Mirtazapine plus gemcitabine as experimental arm
Drug: Mirtazapine plus gemcitabine
Mirtazapine,15mg/day for 3 days, If patients is durable, the dosage increase to 30mg/day, if the patient is durable, the doctor then will decided whether to increase to 45mg. Gemcitabine 1000mg/M2,d1,d8,q3w
The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.
The inclusion criteria included:
- Patients shall have normal organic function such as liver function, Cardiac function and renal function.
- Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
- Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- Patients should be expected to live no shorter than 1.5 months
The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598584
|Tianjin, Tianjin, China, 300060|
|Study Chair:||Yi Ba, MD, PHD||Tianjin Medical University Cancer Institute and Hospital|