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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine, placebo; Drug: Mirtazapine plus gemcitabine

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • TianjinCIH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients of pancreatic cancer 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

Exclusion Criteria:

1. Patients receiving other anti-cancer drugs;
2. 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;
3. Patient with inadequate Blood system,liver function and renal function.
4. Brain metastasis is of symptoms
5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
6. Chronic enteritis or intestinal obstruction
7. Bone marrow failure
8. Mental disease difficult to control
9. Participated other clinic trial within 3 months
10. Pregnant or lactation patients
11. The researcher evaluate the patient is not suitable for this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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; Other Names: Gemcitabine; placebo; pancreatic cancer; randomised control trial
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; Other Names: Gemcitabine; Mirtazapine; pancreatic cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Yi Ba, MD, PHD, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 5, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: placebo; RCT; pancreatic cancer; gemcitabine; Mirtazapine
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Gemcitabine; Mirtazapine
• Other Study ID Numbers: TJ20111123