Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT01598584|
Recruitment Status : Withdrawn (Gemcitabine is not the first choice for most pancreatic cancer patients nowdays)
First Posted : May 15, 2012
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Mirtazapine plus gemcitabine Drug: Gemcitabine, placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (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|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598584
|Tianjin, Tianjin, China, 300060|
|Study Chair:||Yi Ba, MD, PHD||Tianjin Medical University Cancer Institute and Hospital|