Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Phase I Study of M2ES Combined Gemcitabine in 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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: M2ES 7.5mg; Drug: M2ES 15mg; Drug: M2ES 30mg; Drug: M2ES 45mg

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhaosheng Li, MD; Phone Number: 8621-81873241; Email: zhsli@81890.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Changhai Hospital
      • Contact: Zhaosheng Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M2ES-A	Drug: M2ES 7.5mg; M2ES Dosage：7.5mg/m2; Other Names: M2ES
Experimental: M2ES-B	Drug: M2ES 15mg; M2ES Dosage：15mg/m2; Other Names: M2ES
Experimental: M2ES-C	Drug: M2ES 30mg; M2ES Dosage：30mg/m2; Other Names: M2ES
Experimental: M2ES-D	Drug: M2ES 45mg; M2ES Dosage：45mg/m2; Other Names: M2ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerant dose	8 week

Secondary Outcome Measures

Outcome Measure	Time Frame
objective response rate	8 weeks

Collaborators and Investigators

• Sponsor: Protgen Ltd
• Investigators: Principal Investigator: Zhaosheng Li, MD, Shanghai Changhai Hosptial

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 18, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: M2ES2010-1