Decitabine Combined With Gemcitabine in First-line Treatment of AdvancedPancreatic Cancer (SLOWDOSE001)

February 13, 2016 updated by: The First Hospital of Jilin University

Clinical Study of Low Dose of Decitabine Combined With Gemcitabine in First-line Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

The purpose of this study is to investigate the effect of very low dose decitabine combinate with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic pancreatic cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study intends to advanced pancreatic cancer with row standard with district group random way is divided into two groups, a group for the gemcitabine monotherapy in the treatment group, another group of gemcitabine combined with low dose of decitabine treatment group. The overall survival, progression free survival, and disease control rate were observed in patients treated with combined therapy. At the same time, its safety and tolerance were observed. The methylation status and its influence on the immune function were also detected by biological test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histology or cytology proved to be a local development, non excision or metastatic pancreatic cancer patients. Or clinical compliance, but the pathological specimens were difficult, can be fully communicated with patients, selected clinical research.
  • in the treatment of advanced cancer with no anti tumor drug.
  • the damage had been recovered by other treatments, in which patients received surgery for more than 2 weeks.
  • aged 18-70 years
  • the physical condition ECOG score (PS) is 0-1
  • the expected survival time is greater than or equal to 12 weeks
  • according to RECIST standard 1.1 there is at least one measurable lesion, and the lesion is irradiated with at least one measurable lesion. Any of the following methods can accurately measure the diameter of the lesions, the abdominal computed tomography CT or MRI, the conventional method of diameter of at least 20mm or the application of spiral CT diameter at least 10mm.
  • the main organ function is normal, that is, in line with the following standards:(1) blood examination standard should meet: HB than 90g/L (without blood transfusion within 14 days), ANC = 1.5 * 109/L; PLT = 100 * 109/L.(2) biochemical examination must meet the following criteria: serum bilirubin is less than or equal to 1.5 times the upper limit of normal value, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) is less than or equal to 2.5 times the upper limit of the normal value of (if have hepatic metastasis allows ast, ALT is less than or equal to five times the upper limit of normal value). Serum creatinine was 1.5 times the upper limit of the normal value; creatinine clearance rate was 50mL/min.
  • women of childbearing age must have a pregnancy test (serum or urine) within 7 days of entry, and the results are negative, and are willing to use appropriate methods of contraception within 8 weeks of the trial period and the last administered drugs. For men, must be agreed during the test and 8 weeks after administration of the test drug use contraceptive methods or surgical sterilization is appropriate.
  • patients with good compliance.
  • patients understand and voluntarily sign written informed consent.

Exclusion Criteria:

  • the current or previous diagnosis of pancreatic cancer had no systemic anticancer therapy, including cytotoxic drug therapy, target to drug treatment, test treatment, auxiliary chemotherapy or neoadjuvant chemotherapy patients (but stopping for more than 6 months postoperative recurrence patients can be selected).
  • patients with no measurable lesions, such as malignant pleural effusion and ascites, lymph node metastasis, bone metastasis, and brain spinal cord membrane.
  • any effect on the patient's intravenous injection, and any effect on the absorption of the drug or the pharmacokinetic parameters of the drug.
  • patients with systemic disease (such as unstable or non compensatory respiratory, cardiac, liver or kidney disease) with severe or no control. Any unstable systemic disease (including active infection, grade four hypertension, unstable angina, congestive heart failure, liver and kidney, or metabolic disease). Any other malignant tumor in the five years (except for the complete cure of cervical carcinoma in situ or basal cell or squamous cell skin cancer). There is a history of clear neurological or mental disorders, including epilepsy or dementia.
  • patients with the functional level of the various organs of the functional level of the existence of any other important clinical abnormalities or laboratory results so that patients do not fit to participate in the study of evidence. According to the National Cancer Institute common chemotherapy toxicity grading standards (NCI-CTC, 4 edition) has more than 2 levels of chronic toxicity (not including hair loss) not cured.
  • known any severe allergic components of decitabine, gemcitabine.
  • previous studies have been registered for the treatment of this study, or from the patients in this study were unable to enter the group.
  • pregnancy or lactation women. 9) the researchers believe that the subjects may not be able to complete the study or may not be able to comply with the requirements of this study (as a result of management reasons or other reasons).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: decitabine & gemcitabine

This group was treated by low dose decitabine combinated with gemcitabine regimen. decitabine: 5mg/m2 d1-d5; gemcitabine: 1.0g/m2,d8,d15,d22. 28days for one cycle.

every 28days for one cycle
Drug: Decitabine
decitabine 5mg/m2,d1-d5;
Drug: Gemcitabine
gemcitabine 1.0g/m2, d8,d15,d22
Active Comparator: gemcitabine
This group was treated by gemcitabine only. Gemcitabine: 1.0g/m2, d8,d15,d22; 28 days for one cycle. every 28days for one cycle
Drug: Gemcitabine
gemcitabine 1.0g/m2, d8,d15,d22

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Evidence of the size of the lesion in pancreas confirmed by non-investigational CT or MRI
Time Frame: within every 28 days(plus or minus 3 days) ,up to 36 days. From date of randomization until the date of death from any cause, assessed up to 50 months.
within every 28 days(plus or minus 3 days) ,up to 36 days. From date of randomization until the date of death from any cause, assessed up to 50 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLOWDOSE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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