Status:
UNKNOWN
Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure
Lead Sponsor:
Protgen Ltd
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine trea...
Detailed Description
To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with th...
Eligibility Criteria
Inclusion
- histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
- Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- 18 years of age or older
- Karnofsky performance status (KPS) of 60-100 points
- 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 ≥3.5×109/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin≥9g/dL, total bilirubin ≤2.5 upper limit of normal \[ULN\],AST≤2.5 ULN, or≤5 ULN if there was evidence of liver metastases;alkaline phosphatase≤ 2.5 ULN, or≤ 5 ULN if there was evidence of liver Metastases creatinine clearance≤50 mL/min,
- life expectancy of at least 12 weeks
Exclusion
- patients had clinically apparent CNS metastases or 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 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
- more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
- major surgery within the prior 6 weeks;
- Pregnant or lactating women
- tumor involvement of major blood vessels
- uncontrolled intercurrent illness
- A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina
- clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)
- urine protein ≥ 500 mg in 24 hours;
- evidence of bleeding diathesis or coagulopathy
- Patients on therapeutic doses of low-molecular weight heparin
- Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01219192
Start Date
August 1 2010
End Date
December 1 2011
Last Update
October 28 2010
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060