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

NCT00662688 | Terminated Phase 3

• 5 other identifiers: CDR0000593019GERCOR-PAM07-D07-2EUDRACT 2007-002115-59EU-20837PFIZER-GERCOR-PAM07-D07-2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

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.

Conditions

Chemotherapeutic Agent Toxicity; Pancreatic Cancer; Thromboembolism

Keywords

thromboembolism; chemotherapeutic agent toxicity; adenocarcinoma of the pancreas; stage IV pancreatic cancer; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Thromboembolic events

  number of thromboembolic events during anticoagulation treatment

  during study treatment

Secondary Outcomes (3)

• Progression-free survival

  at 6 months

• Overall survival

  at one year

• Tolerance of regimens

  each cycle

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

chemotherapy at investigator's discretion

Drug: Chemotherapy at the investigator's discretion

dalteparin

EXPERIMENTAL

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

Drug: daltéparine; Drug: Chemotherapy at the investigator's discretion

Interventions

daltéparine DRUG

dalteparin

Chemotherapy at the investigator's discretion DRUG

chemotherapy; dalteparin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (6)

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

Montfermeil, 93370, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (1)

• 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.

  PMID: 33337539 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Thromboembolism

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Benoist Chibauldel, MD

  Hopital Saint Antoine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 21, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

FR (6)