Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01598584
First received: May 5, 2012
Last updated: June 12, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Mirtazapine plus gemcitabine
Drug: Gemcitabine, placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • quality of life [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    primary outcome is the quality of life evaluated by SF-36 scale


Secondary Outcome Measures:
  • anxiety and depression scores [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    The second outcomes include anxious and depression scores

  • objective response rate [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • progress free survival, [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • overall Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • chemotherapy induced nausea and vomiting [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • placebo
  • Gemcitabine
  • 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:
  • Mirtazapine
  • Gemcitabine
  • pancreatic cancer

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598584

Contacts
Contact: Yi Ba, M.D,PHD +8613920893142 zhoubaling123@163.com

Locations
China, Tianjin
TianjinCIH Recruiting
Tianjin, Tianjin, China, 300060
Contact: Yi Ba, MD.PHD    +8613920893142    zhoubaling123@163.com   
Sub-Investigator: likun Zhou, MD         
Sub-Investigator: Hongli Li, MD.PHD         
Sub-Investigator: Dingzhi Huang, MD,PHD         
Sub-Investigator: Weidong Ma, MD.PHD         
Sub-Investigator: yong Tang, MD.PHD         
Sub-Investigator: Ting Deng, MD.         
Sub-Investigator: Xia Wang, MD         
Sub-Investigator: Ming Bai, MD         
Sub-Investigator: Rubing Han, MD.PHD         
Sub-Investigator: Rui Liu, MD.PHD         
Sub-Investigator: Shaohua Ge, MD.PHD         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Chair: Yi Ba, MD, PHD Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01598584     History of Changes
Other Study ID Numbers: TJ20111123
Study First Received: May 5, 2012
Last Updated: June 12, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Mirtazapine
gemcitabine
placebo
RCT
pancreatic cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Mirtazapine
Mianserin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on August 01, 2014