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Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Information source: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: Mirtazapine plus gemcitabine (Drug); Gemcitabine, placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Tianjin Medical University Cancer Institute and Hospital

Official(s) and/or principal investigator(s):
Yi Ba, MD, PHD, Study Chair, Affiliation: Tianjin Medical University Cancer Institute and Hospital

Overall contact:
Yi Ba, M.D,PHD, Phone: +8613920893142, Email: zhoubaling123@163.com

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.

Clinical Details

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

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

Primary outcome: quality of life

Secondary outcome:

anxiety and depression scores

objective response rate

progress free survival,

overall Survival

chemotherapy induced nausea and vomiting

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Yi Ba, M.D,PHD, Phone: +8613920893142, Email: zhoubaling123@163.com

TianjinCIH, Tianjin, Tianjin 300060, China; Recruiting
Yi Ba, MD.PHD, Phone: +8613920893142, Email: zhoubaling123@163.com
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, Sub-Investigator
Additional Information

Starting date: June 2012
Last updated: June 12, 2013

Page last updated: August 23, 2015

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