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Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced Pancreatic Cancer

Phase 1
18 Years
60 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced 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.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerant dose

Outcome Time Frame:

8 week

Safety Issue:


Principal Investigator

Zhaosheng Li, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Changhai Hosptial


China: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

December 2011

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms