Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer

NCT ID: NCT00662688

Last Updated: 2013-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.

PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.

Detailed Description

OBJECTIVES:

Primary

• To demonstrate that preventive anticoagulation with dalteparin reduces the number of thromboembolic events.
• To determine the number of thromboembolic events occurring with preventive anticoagulation.

Secondary

• To determine survival without thrombotic event.
• To determine progression-free and overall survival.
• To determine time to response of tumor.
• To assess tolerance of these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 4 treatment arms.

• Arm A: Patients receive chemotherapy at investigator's discretion
• Arm B Patients receive chemotherapy at investigator's discretion and dalteparin In all arms, treatment repeats in the absence of disease progression or unacceptable toxicity.

Blood and plasma samples are obtained at baseline and periodically during study. Blood is examined for biomarkers, resistance to activated protein C, and mutations (Leiden V factor, mutation G20210A, and the factor II gene). Thrombin generation and factors VIIa and VIII are assessed in plasma.

After completion of study therapy, patients are followed periodically.

Conditions

Chemotherapeutic Agent Toxicity; Pancreatic Cancer; Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

chemotherapy

chemotherapy at investigator's discretion

Group Type: ACTIVE_COMPARATOR

Chemotherapy at the investigator's discretion

Intervention Type: DRUG

dalteparin

dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.

Group Type: EXPERIMENTAL

daltéparine

Intervention Type: DRUG

Chemotherapy at the investigator's discretion

Intervention Type: DRUG

Interventions

daltéparine

Intervention Type: DRUG

Chemotherapy at the investigator's discretion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas

• Metastatic disease
• Not amenable to treatment
• No localized or locally advanced disease
• Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI
• No progressive thrombo-embolic disease
• No adenocarcinoma of the biliary tract or ampulla of Vater
• No known CNS metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Life expectancy > 12 weeks
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL
• Alkaline phosphatase < 5 times normal
• Bilirubin < 1.5 times normal
• Creatinine < 1.5 times normal
• Creatinine clearance < 30 mL/min
• Pain controlled or stabilized via analgesic therapy
• Affiliation with social security system
• Not pregnant or nursing
• No controlled or uncontrolled jaundice
• No contraindication to study drugs
• No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
• No serious cardiac and/or respiratory disease
• No other cancer in the past 5 years except the following cancers, provided they have been completely resected:

• Skin cancer
• Localized melanoma
• Carcinoma in situ of the cervix
• No history of thrombophilia
• No history of heparin-induced thrombocytopenia
• No uncontrolled or persistent hypercalcemia
• No psychological, familial, social, and/or geographical condition that precludes participation in the study

PRIOR CONCURRENT THERAPY:

• No prior hematologic therapy for metastatic disease
• No prior abdominal radiotherapy
• No concurrent corticosteroids as anti-emetic therapy
• No other concurrent anticoagulation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benoist Chibauldel, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Saint Antoine

Locations

Centre Hospitalier de Meaux

Meaux, , France

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

Montfermeil, , France

Hopital Bichat - Claude Bernard

Paris, , France

Hopital Saint Antoine

Paris, , France

CHU Pitie-Salpetriere

Paris, , France

Hopital Foch

Suresnes, , France

Countries

France

References

Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

Reference Type: DERIVED

PMID: 33337539 (View on PubMed)

Other Identifiers

GERCOR-PAM07-D07-2

Identifier Type: -

Identifier Source: secondary_id

EUDRACT 2007-002115-59

Identifier Type: -

Identifier Source: secondary_id

EU-20837

Identifier Type: -

Identifier Source: secondary_id

PFIZER-GERCOR-PAM07-D07-2

Identifier Type: -

Identifier Source: secondary_id

CDR0000593019

Identifier Type: -

Identifier Source: org_study_id