Clinical trial NCT01598584: Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
Official title: A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Pancreatic Cancer
Keywords: Mirtazapine
gemcitabine
placebo
RCT
pancreatic cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: quality of life
timeFrame: up to 3 years
Secondary outcomes:
measure: anxiety and depression scores
timeFrame: up to 3 years
measure: objective response rate
timeFrame: up to 3 years
measure: progress free survival,
timeFrame: up to 3 years
measure: overall Survival
timeFrame: up to 3 years
measure: chemotherapy induced nausea and vomiting
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: TianjinCIH
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Yi Ba, MD, PHD
role: STUDY_CHAIR
References: