Pancreatic CancerPhase 2/3NCT01598584
Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer
A Phase 2/3 study testing Mirtazapine plus gemcitabine in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Mirtazapine plus gemcitabine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
- 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.
- Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- Patients should be expected to live no shorter than 1.5 months
Who cannot join
- Patients receiving other anti-cancer drugs;
- 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;
- Patient with inadequate Blood system,liver function and renal function.
- Brain metastasis is of symptoms
- Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
- Chronic enteritis or intestinal obstruction
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- Bone marrow failure
- Mental disease difficult to control
- Participated other clinic trial within 3 months
- Pregnant or lactation patients
- The researcher evaluate the patient is not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Patients shall have normal organic function such as liver function, Cardiac function and renal function.
- 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.
- Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Mirtazapine plus gemcitabine, Gemcitabine, placebo
- Keywords
- Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine plus gemcitabineDrug
Also called Mirtazapine, Gemcitabine, pancreatic cancer
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
Gemcitabine, placeboDrug
Also called placebo, Gemcitabine, pancreatic cancer, randomised control trial
Gemcitabine 1.0g/m2,d1,d8,q3w placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo plus gemcitabine | Placebo comparator | we design placebo plus gemcitabine as control arm Receives: Drug: Gemcitabine, placebo |
| Mirtazapine plus gemcitabine | Experimental | We design Mirtazapine plus gemcitabine as experimental arm Receives: Drug: Mirtazapine plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
primary outcome is the quality of life evaluated by SF-36 scale
Measured: up to 3 years
Secondary outcomes (5)
anxiety and depression scores
The second outcomes include anxious and depression scores
Measured: up to 3 years
objective response rate
Measured: up to 3 years
progress free survival,
Measured: up to 3 years
overall Survival
Measured: up to 3 years
chemotherapy induced nausea and vomiting
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Gemcitabine is not the first choice for most pancreatic cancer patients nowdays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Ba, MD, PHD, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598584
- Sponsor's protocol ID
- TJ20111123
- Status last verified
- Dec 2012
- First submitted
- 5 May 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01598584
- Acronym / sponsor ID
- TJ20111123
- Conditions
- Pancreatic Cancer
- Keywords
- Mirtazapine, gemcitabine, placebo, RCT, pancreatic cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Gemcitabine is not the first choice for most pancreatic cancer patients nowdays
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients shall have normal organic function such as liver function, Cardiac function and renal function.
- 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.
- Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo plus gemcitabine | Placebo comparator | Drug: Gemcitabine, placebowe design placebo plus gemcitabine as control arm |
| Mirtazapine plus gemcitabine | Experimental | Drug: Mirtazapine plus gemcitabineWe design Mirtazapine plus gemcitabine as experimental arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
- 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.
- Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
- Patients should be expected to live no shorter than 1.5 months
Key exclusion criteria (11 listed)
- Patients receiving other anti-cancer drugs;
- 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;
- Patient with inadequate Blood system,liver function and renal function.
- Brain metastasis is of symptoms
- Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine plus gemcitabineAlso: Mirtazapine, Gemcitabine, pancreatic cancerMirtazapine,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 | Drug | Mirtazapine plus gemcitabine |
| Gemcitabine, placeboAlso: placebo, Gemcitabine, pancreatic cancer, randomised control trialGemcitabine 1.0g/m2,d1,d8,q3w placebo | Drug | placebo plus gemcitabine |
Primary outcome
quality of life
Time frame: up to 3 years
primary outcome is the quality of life evaluated by SF-36 scale
5 secondary outcomes
anxiety and depression scores
Time frame: up to 3 years
objective response rate
Time frame: up to 3 years
progress free survival,
Time frame: up to 3 years
overall Survival
Time frame: up to 3 years
chemotherapy induced nausea and vomiting
Time frame: up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ba, MD, PHD study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mirtazapine plus gemcitabine in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.