Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ERYtech Pharma
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

• Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed

• Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM (primary tumor, regional nodes, metastasis) 2002 classification (UICC 2002)

• resistant to a first or second line chemotherapy with gemcitabine

• Patient aged between 18 to 70 years

• Signed Informed Consent Form

• Life expectancy ≥ 12 weeks

• Accurate measurement of tumor volume by imagery (in at least one dimension)

• Presence of one or several tumor markers (carcinoembryonic antigen [CEA] and cancer antigen [CA] 19.9)

• Eastern Cooperative Oncology Group [ECOG] Prognostic Score : 0, 1 or 2

• Patient beneficiary of a Social Security Insurance

Exclusion Criteria:

• Patient with an endocrine or acinar pancreatic tumor

• Patient with known or suspected cerebro-meningeal metastases

• Haemoglobin level greater than 13 g/L

• Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase

• Splenic vein thrombosis < 3 months or under active treatment

• Anti-vitamin K treatment

• Hepatic Insufficiency unrelated to pancreatic cancer

• Renal insufficiency unrelated to pancreatic cancer

• Pancreatitis or pancreatitis history unrelated to pancreatic cancer

• Insulin-dependant diabetes mellitus unrelated to pancreatic cancer

• Current or prior coagulopathy disorders unrelated to pancreatic cancer

• ECOG Prognostic Score 3 or 4

• History of grade 3 blood transfusion reaction (life threatening situation)

• Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient

• Patient already included in another clinical trial

• Pregnancy, breast-feeding or absence of secured contraception

• Unwillingness to sign the informed consent form