Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

This study is currently recruiting participants.
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

May 5, 2012
June 12, 2013
June 2012
June 2015   (final data collection date for primary outcome measure)
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
quality of life - A phase II/III prospective randomized placebo-control trail compare Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
primary outcome is the quality of life evaluated by SF-36 scale
Complete list of historical versions of study NCT01598584 on ClinicalTrials.gov Archive Site
  • 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 ]
  • anxiety and depression scores - A phase II/III prospective randomized placebo-control trail compare Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer [ 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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Pancreatic Cancer
  • 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
  • Drug: Gemcitabine, placebo
    Gemcitabine 1.0g/m2,d1,d8,q3w placebo
    Other Names:
    • placebo
    • Gemcitabine
    • pancreatic cancer
    • randomised control trial
  • Placebo Comparator: placebo plus gemcitabine
    we design placebo plus gemcitabine as control arm
    Intervention: Drug: Gemcitabine, placebo
  • Experimental: Mirtazapine plus gemcitabine
    We design Mirtazapine plus gemcitabine as experimental arm
    Intervention: Drug: Mirtazapine plus gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Yi Ba, M.D,PHD +8613920893142 zhoubaling123@163.com
China
 
NCT01598584
TJ20111123
Yes
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Study Chair: Yi Ba, MD, PHD Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP