Safety and Efficacy of Clopidogrel in Locally Advanced and Metastatic Pancreatic Adenocarcinoma Treated With Chemotherapy

• Status: Terminated
• Trial end date: 2018-03-27
• Target enrollment: 0
• Participant gender: All

Summary

Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine tumor.

In a pilot study, the rate of microparticles was correlated with response rate of pancreatic adenocarcinoma.

The aim of the study is;

• to compare the phenotypes of coagulation, the tumor progression and metastasis formation with and without clopidogrel treatment in association with chemotherapy in advanced pancreatic cancer patients

• to correlate the decrease of microparticles levels after one month of chemotherapy with tumor response (ancillary study)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Groupe Francophone Thrombose et Cancer
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• 18 years of age or older

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Locally advanced or metastatic pancreatic cancer

• Measurable primary pancreatic cancer or metastasis

• No previous chemotherapy either in an adjuvant or metastatic setting

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Adequate bone marrow: granulocyte count ≥ 1.5 G/L; and platelet count ≥ 100 G/L

• Adequate liver function: bilirubin ≤ 2 times the upper limit of the normal range, transaminases (AST and ALT) ≤ 3 times the upper limit of the normal range

• Adequate renal function: calculated clearance rate > 60 m.mn-1 (Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula)

• Women of childbearing potential must use an effective birth control method

Exclusion Criteria:

• Endocrine or acinar pancreatic carcinoma

• Pancreatic metastasis of other primary tumors

• Previous radiotherapy for measurable lesions

• Previous chemotherapy

• History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis

• Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for > 5 years are allowed.

• Known HIV disease requiring antiretroviral treatment

• Hemorrhagic diathesis

• Aspirin with a daily dose > 75 mg

• Curative dose of LMWH

• Recent venous thromboembolism (< 1 year)

• Patients under VKA

• Lesion of the digestive tract that could be hemorrhagic with clopidogrel treatment

• Active infection

• Chronic diarrhea

• Cardiac disease with a left ventricular ejection fraction below 45%

• Hypersensitivity to clopidogrel or its excipients

• Patients with severe hepatic impairment

• Patients who are pregnant or breast feeding, or who are not using effective birth control methods

• Participation in another clinical research protocol, participation in a trial of routine care is authorized at the same time as PANCREADOGREL

• Patient under tutorship or curatorship

• Patients unwilling or unable to comply with the protocol

• Not affiliated to health system ("bénéficiaire ou ayant droit")