Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer (PAM07)
This study has been terminated.
(recruitment prematurely stopped due to a lack of eligible patients.)
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00662688
First received: April 18, 2008
Last updated: March 12, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapeutic Agent Toxicity Pancreatic Cancer Thromboembolism |
Drug: daltéparine Drug: Chemotherapy at the investigator's discretion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas |
Resource links provided by NLM:
Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
Primary Outcome Measures:
- Thromboembolic events [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]number of thromboembolic events during anticoagulation treatment
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: at one year ] [ Designated as safety issue: No ]
- Tolerance of regimens [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
| Enrollment: | 42 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: chemotherapy
chemotherapy at investigator's discretion
|
Drug: Chemotherapy at the investigator's discretion |
|
Experimental: dalteparin
dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
|
Drug: daltéparine Drug: Chemotherapy at the investigator's discretion |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662688
Locations
| France | |
| Centre Hospitalier de Meaux | |
| Meaux, France, 77104 | |
| Centre Hospitalier Intercommunal Le Raincy - Montfermeil | |
| Montfermeil, France, 93370 | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Foch | |
| Suresnes, France, 92151 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Principal Investigator: | Benoist Chibauldel, MD | Hopital Saint Antoine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
| ClinicalTrials.gov Identifier: | NCT00662688 History of Changes |
| Other Study ID Numbers: | CDR0000593019, GERCOR-PAM07-D07-2, EUDRACT 2007-002115-59, EU-20837, PFIZER-GERCOR-PAM07-D07-2 |
| Study First Received: | April 18, 2008 |
| Last Updated: | March 12, 2013 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament |
Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
|
thromboembolism chemotherapeutic agent toxicity adenocarcinoma of the pancreas stage IV pancreatic cancer recurrent pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Thromboembolism 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 |
Thrombosis Dalteparin Heparin, Low-Molecular-Weight Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013