Status:
UNKNOWN
Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer
Lead Sponsor:
Protgen Ltd
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- No prior chemotherapy was allowed.
- Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- 18 to 60 years of age
- Karnofsky performance status (KPS) of 60-100 points
- Unidimensionally measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- 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.
- life expectancy of at least 12 weeks.
- All patients provided written informed consent according to federal and institutional guidelines.
Exclusion
- patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
- 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.
- more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
- radiation therapy have not been completed 4 weeks before enrollment.
- major surgery within the prior 4 weeks;
- participating any clinical trial within the prior 4 weeks;
- Pregnant or lactating women.
- tumor involvement of major blood vessels
- 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.
- chronic renal disease.
- urine protein ≥ 500 mg in 24 hours;
- prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis.
- pulmonary embolus, or deep venous thrombosis
- ECG: QTC ≥ 480 ms
- Patients on therapeutic doses of heparin or antiplatelet agents.
- Patients who received thrombolytic agents or who required full-dose anticoagulation
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01218880
Start Date
June 1 2010
End Date
December 1 2011
Last Update
October 19 2010
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433