Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01218880
• Other study ID #: M2ES2010-1
• Status: Recruiting
• Phase: Phase 1
• First received: October 8, 2010
• Last updated: October 18, 2010
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Protgen Ltd
• Contact: Zhaosheng Li, MD
• Phone: 8621-81873241
• Email: zhsli[@]81890.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• M2ES 7.5mg
M2ES Dosage:7.5mg/m2
• M2ES 15mg
M2ES Dosage:15mg/m2
• M2ES 30mg
M2ES Dosage:30mg/m2
• M2ES 45mg
M2ES Dosage:45mg/m2

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Protgen Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerant dose		8 week	Yes
Secondary	objective response rate		8 weeks	No