Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

NCT01598584 | Withdrawn Phase 2 DMC

• 1 other identifier: TJ20111123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Mirtazapine; gemcitabine; placebo; RCT; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• quality of life

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

  up to 3 years

Secondary Outcomes (5)

• anxiety 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

Study Arms (2)

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

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

Also known as: Mirtazapine, Gemcitabine, pancreatic cancer

Mirtazapine plus gemcitabine

Gemcitabine, placebo DRUG

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

Also known as: placebo, Gemcitabine, pancreatic cancer, randomised control trial

placebo plus gemcitabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Mirtazapine; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yi Ba, MD, PHD

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2012
• First Posted: May 15, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2012-12

Locations

CN (1)