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

NCT02404363 | Terminated Phase 3 DMC

• 2 other identifiers: P1309362014-001463-12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Locally Advanced Pancreatic Cancer; Adenocarcinoma, Pancreas; Metastatic Pancreatic Cancer

Keywords

Clopidogrel; Pancreatic Cancer; Efficacy; Chemotherapy; Microparticles; Disease free survival; First line chemotherapy

Outcome Measures

Primary Outcomes (1)

• Response to treatment based on RECIST 1.1 criterion

  Progression free survival

  up to 6 months

Secondary Outcomes (4)

• Venous thromboembolic events

  up to 12 months

• Response to treatment based on RECIST 1.1 criterion

  up to 12 months

• Overall survival

  up to 12 months

• Bleedings

  up to 12 months

Study Arms (2)

Clopidogrel

EXPERIMENTAL

Clopidogrel tablets 75 mg for six months:

Drug: Clopidogrel

Comparator

PLACEBO COMPARATOR

Placebo tablet 75 mg for six months:

Drug: Placebo

Interventions

Clopidogrel DRUG

Clopidogrel tablets 75 mg for six months: In case of treatment with aspirin \< or = 75 mg/d or prophylactic LMWH --\> clopidogrel 75 mg/d If aspirin = 0 + LMWH = 0 --\> clopidogrel 150 mg/d x 7days then 75mg/d

Clopidogrel

Placebo DRUG

Placebo tablets 75 mg for six months: In case of treatment with aspirin \< or = 75 mg/d or prophylactic LMWH --\> placebo 75 mg/d If aspirin = 0 + LMWH = 0 --\> placebo 150 mg/d x 7days then 75mg/d

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Groupe Francophone Thrombose et Cancer: collaborator

Study Sites (1)

Service d'oncologie digestive - Institut Sainte Catherine

Avignon, 84918, France

Location

MeSH Terms

Conditions

Adenocarcinoma; Pancreatic Neoplasms

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Philippe DEBOURDEAU, MD

  Institut Sainte Catherine - Avignon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 31, 2015
• Study Start: January 11, 2016
• Primary Completion: December 4, 2017
• Study Completion: March 27, 2018
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

FR (1)