Gemcitabine With or Without Capecitabine and/or Dalteparin in Treating Patients With Metastatic Pancreatic Cancer - Full Text View

Sponsored by:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00662688

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: capecitabine Drug: dalteparin Drug: gemcitabine hydrochloride Genetic: mutation analysis Other: laboratory biomarker analysis	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Capecitabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Number of thromboembolic events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Thromboembolic-related survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Time to response of tumor [ Designated as safety issue: No ]
Tolerance of regimens [ Designated as safety issue: Yes ]

Estimated Enrollment:	136
Study Start Date:	October 2007
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

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 1A: Patients receive gemcitabine hydrochloride IV over 150 minutes on days 1 and 15.
Arm 1B: Patients receive gemcitabine hydrochloride as in arm 1A and dalteparin subcutaneously on day 1.
Arm 2A: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral capecitabine every 12 hours on days 1-21.
Arm 2B: Patients receive gemcitabine hydrochloride and capecitabine as in arm 2A and dalteparin as in arm 1B. In all arms, treatment repeats every 28 days 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 Intercommunal Le Raincy - Montfermeil	Recruiting
Montfermeil, France, 93370
Contact: Contact Person 33-1-41-70-80-00
CHU Pitie-Salpetriere	Recruiting
Paris, France, 75651
Contact: Contact Person 33-1-42-16-00-00
Hopital Bichat - Claude Bernard	Recruiting
Paris, France, 75018
Contact: Contact Person 33-1-4025-7000
Hopital Foch	Recruiting
Suresnes, France, 92151
Contact: Contact Person 33-8-26-20-72-20
Hopital Saint Antoine	Recruiting
Paris, France, 75571
Contact: Contact Person 33-1-4928-2336 benoist.chabaudel@sat.aphp.fr

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Principal Investigator:

Benoist Chibauldel, MD

Hopital Saint Antoine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00662688 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Pancreatic Neoplasms
Fibrinolytic Agents
Pancrelipase
Thromboembolism
Fibrin Modulating Agents
Neoplasm Metastasis
Gemcitabine
Endocrine Gland Neoplasms
Capecitabine
Anticoagulants
Digestive System Neoplasms
Vascular Diseases

Endocrine System Diseases
Cardiovascular Agents
Antiviral Agents
Immunosuppressive Agents
Thrombosis
Recurrence
Embolism and Thrombosis
Digestive System Diseases
Radiation-Sensitizing Agents
Embolism
Dalteparin
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Thromboembolism
Fibrin Modulating Agents
Neoplasms by Site
Therapeutic Uses
Cardiovascular Diseases

Gemcitabine
Endocrine Gland Neoplasms
Capecitabine
Anticoagulants
Digestive System Neoplasms
Vascular Diseases
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents
Antiviral Agents
Thrombosis
Pharmacologic Actions
Embolism and Thrombosis
Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009