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Clinical Trial Record

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Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

2010-06

2011-07

2011-12

21

Study Overview

Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.

Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.

  • Pancreatic Cancer
  • DRUG: M2ES 7.5mg
  • DRUG: M2ES 15mg
  • DRUG: M2ES 30mg
  • DRUG: M2ES 45mg
  • M2ES2010-1

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 Registration Dates Results Reporting Dates Study Record Updates

2010-10-08  

N/A  

2010-10-18  

2010-10-08  

N/A  

2010-10-19  

2010-10-11  

N/A  

2010-09  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: M2ES-A

DRUG: M2ES 7.5mg

  • M2ES Dosage：7.5mg/m2
EXPERIMENTAL: M2ES-B

DRUG: M2ES 15mg

  • M2ES Dosage：15mg/m2
EXPERIMENTAL: M2ES-C

DRUG: M2ES 30mg

  • M2ES Dosage：30mg/m2
EXPERIMENTAL: M2ES-D

DRUG: M2ES 45mg

  • M2ES Dosage：45mg/m2
Primary Outcome MeasuresMeasure DescriptionTime Frame
Maximum tolerant dose8 week
Secondary Outcome MeasuresMeasure DescriptionTime Frame
objective response rate8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zhaosheng Li, MD

Phone Number: 8621-81873241

Email: zhsli@81890.net

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery. 2. No prior chemotherapy was allowed. 3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port. 4. 18 to 60 years of age 5. Karnofsky performance status (KPS) of 60-100 points 6. Unidimensionally measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria 7. Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤2 upper limit of normal [ULN],AST ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min. 8. life expectancy of at least 12 weeks. 9. All patients provided written informed consent according to federal and institutional guidelines.
    Exclusion Criteria:
    1. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.) 2. another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix. 3. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry. 4. radiation therapy have not been completed 4 weeks before enrollment. 5. major surgery within the prior 4 weeks; 6. participating any clinical trial within the prior 4 weeks; 7. Pregnant or lactating women. 8. tumor involvement of major blood vessels 9. uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 6 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection. 10. chronic renal disease. 11. urine protein ≥ 500 mg in 24 hours; 12. prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis. 13. pulmonary embolus, or deep venous thrombosis 14. ECG: QTC ≥ 480 ms 15. Patients on therapeutic doses of heparin or antiplatelet agents. 16. Patients who received thrombolytic agents or who required full-dose anticoagulation

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: Zhaosheng Li, MD, Shanghai Changhai Hosptial

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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