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Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Withdrawn

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Mirtazapine plus gemcitabine

Gemcitabine, placebo

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of pancreatic cancer 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

Exclusion Criteria:

Patients receiving other anti-cancer drugs;
Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
Patient with inadequate Blood system,liver function and renal function.
Brain metastasis is of symptoms
Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
Chronic enteritis or intestinal obstruction
Bone marrow failure
Mental disease difficult to control
Participated other clinic trial within 3 months
Pregnant or lactation patients
The researcher evaluate the patient is not suitable for this trial.

Sites / Locations

TianjinCIH

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo plus gemcitabine

Mirtazapine plus gemcitabine

Arm Description

we design placebo plus gemcitabine as control arm

We design Mirtazapine plus gemcitabine as experimental arm

Outcomes

Primary Outcome Measures

quality of life

primary outcome is the quality of life evaluated by SF-36 scale

Secondary Outcome Measures

anxiety and depression scores

The second outcomes include anxious and depression scores

objective response rate

progress free survival,

overall Survival

chemotherapy induced nausea and vomiting

Full Information

NCT ID

NCT01598584

First Posted

May 5, 2012

Last Updated

September 24, 2015

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01598584

Brief Title

Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Gemcitabine is not the first choice for most pancreatic cancer patients nowdays

Study Start Date

June 2012 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo plus gemcitabine

Arm Type

Placebo Comparator

Arm Description

we design placebo plus gemcitabine as control arm

Arm Title

Mirtazapine plus gemcitabine

Arm Type

Experimental

Arm Description

We design Mirtazapine plus gemcitabine as experimental arm

Intervention Type

Drug

Intervention Name(s)

Mirtazapine plus gemcitabine

Other Intervention Name(s)

Mirtazapine, Gemcitabine, pancreatic cancer

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, placebo

Other Intervention Name(s)

placebo, Gemcitabine, pancreatic cancer, randomised control trial

Intervention Description

Gemcitabine 1.0g/m2,d1,d8,q3w placebo

Primary Outcome Measure Information:

Title

quality of life

Description

primary outcome is the quality of life evaluated by SF-36 scale

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

anxiety and depression scores

Description

The second outcomes include anxious and depression scores

Time Frame

up to 3 years

Title

objective response rate

Time Frame

up to 3 years

Title

progress free survival,

Time Frame

up to 3 years

Title

overall Survival

Time Frame

up to 3 years

Title

chemotherapy induced nausea and vomiting

Time Frame

up to 3 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of pancreatic cancer 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 Exclusion Criteria: Patients receiving other anti-cancer drugs; Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation; Patient with inadequate Blood system,liver function and renal function. Brain metastasis is of symptoms Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease; Chronic enteritis or intestinal obstruction Bone marrow failure Mental disease difficult to control Participated other clinic trial within 3 months Pregnant or lactation patients The researcher evaluate the patient is not suitable for this trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Ba, MD, PHD

Organizational Affiliation

Tianjin Medical University Cancer Institute and Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

TianjinCIH

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

12. IPD Sharing Statement

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Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

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