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A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Outcome Measure:

quality of life

Outcome Description:

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

Outcome Time Frame:

up to 3 years

Safety Issue:

Yes

Principal Investigator

Yi Ba, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital

Authority:

China: Food and Drug Administration

Study ID:

TJ20111123

NCT ID:

NCT01598584

Start Date:

June 2012

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Cancer
  • Mirtazapine
  • gemcitabine
  • placebo
  • RCT
  • pancreatic cancer
  • Neoplasm Metastasis
  • Pancreatic Neoplasms

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