NCT01598584

Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

Detailed description

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: 1. Patients shall have normal organic function such as liver function, Cardiac function and renal function. 2. 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. 3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled. 4. 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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
DRUG	Gemcitabine, placebo	Gemcitabine 1.0g/m2,d1,d8,q3w placebo

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-05-15
• Last updated: 2015-09-28

Locations

1 site across 1 country: China