Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metast... | NCT01598584

Studies
Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

NCT01598584

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Withdrawn

Last Update Posted

Sep 28, 2015Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Pancreatic Cancer

Interventions

Mirtazapine plus gemcitabine
Gemcitabine, placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 5, 2012

First Submission Date that Met QC Criteria

May 14, 2012

First Posted Date

May 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2015

Last Update Posted Date

Sep 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo plus gemcitabine	Placebo Comparator	we design placebo plus gemcitabine as control arm	Drug: Gemcitabine, placebo
Mirtazapine plus gemcitabine	Experimental	We design Mirtazapine plus gemcitabine as experimental arm	Drug: Mirtazapine plus gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirtazapine plus gemcitabine	Drug	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yi Ba, MD, PHD	Tianjin Medical University Cancer Institute and Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
TianjinCIH		Tianjin	Tianjin Municipality	300060	China

ID	Term
D010190	Pancreatic Neoplasms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D000078785	Mirtazapine
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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