Mirtazapine Plus Gemcitabine Versus Gemcitabine In Metastasis Pancreatic Cancer

Study Overview

Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

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.

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.

Pancreatic Cancer

DRUG: Mirtazapine plus gemcitabine
DRUG: Gemcitabine, placebo

TJ20111123

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-05-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-09-24
First Submitted that Met QC Criteria 2012-05-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-09-28
First Posted (ESTIMATED) 2012-05-15	Results First Posted N/A	Last Verified 2012-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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

Participant Group/Arm

Intervention/Treatment

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

Primary Outcome Measures	Measure Description	Time Frame
quality of life	primary outcome is the quality of life evaluated by SF-36 scale	up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
anxiety and depression scores	The second outcomes include anxious and depression scores	up to 3 years
objective response rate		up to 3 years
progress free survival,		up to 3 years
overall Survival		up to 3 years
chemotherapy induced nausea and vomiting		up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Yi Ba, MD, PHD, Tianjin Medical University Cancer Institute and Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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