Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075452
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: May 2007
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.
PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: oxaliplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to response [ Designated as safety issue: No ]
- Clinical benefit [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
| Study Start Date: | November 2003 |
OBJECTIVES:
Primary
- Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.
Secondary
- Compare the time of response in patients treated with these regimens.
- Compare the clinical benefit of and tolerance to these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.
After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.
Quality of life is assessed at baseline and then every 2 months.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed pancreatic adenocarcinoma
- Locally advanced or metastatic disease
- Unresectable disease
Measurable disease
- At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
- No adenocarcinoma of the bile ducts or ampulla of Vater
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 12 weeks
Hematopoietic
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 times normal
- Alkaline phosphatase less than 5 times normal
Renal
- Creatinine less than 1.5 times normal
- No uncontrolled or persistent hypercalcemia
Cardiovascular
- No serious cardiac failure
Pulmonary
- No serious respiratory failure
Other
- Pain must be stabilized or controlled before initiation of study treatment
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other untreatable malignant tumor
- No serious psychological, familial, social, or geographical condition that would preclude study participation
- No neuropathy that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No concurrent corticosteroids except for antiemetic therapy
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075452
Locations
| France | |
| Centre Paul Papin | |
| Angers, France, 49036 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Hopital Saint Andre | |
| Bordeaux, France, 33075 | |
| CHU Ambroise Pare | |
| Boulogne Billancourt, France, F-92104 | |
| CMC Bligny | |
| Briis Sous Forges, France, 91640 | |
| Hopital Louis Pasteur | |
| Chartres, France, 28018 | |
| Chu-Hopital Gabriel Montpied | |
| Clermont Ferrand, France, F-63000 | |
| Hopital Beaujon | |
| Clichy, France, 92118 | |
| Hopital Louis Mourier | |
| Colombes, France, F-92701 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Centre Hospitalier Departemental | |
| La Roche Sur Yon, France, F-85025 | |
| Hopital Saint - Louis | |
| La Rochelle, France, 17000 | |
| Centre Hospitalier de Lagny | |
| Lagny Sur Marne, France, 77405 | |
| Hopital Andre Mignot | |
| Le Chesnay, France, 78157 | |
| C. H. Du Mans | |
| Le Mans, France, 72037 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Centre Hospital Universitaire Hop Huriez | |
| Lille, France, 59037 | |
| Hopital de la Croix Rousse | |
| Lyon, France, 69317 | |
| Clinique Saint Jean | |
| Lyon, France, 69008 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 57038 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital de la Croix St. Simon | |
| Paris, France, 75020 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Maison Medicale Marzet | |
| Pau, France, 64000 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95300 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| C. H. De Saumur | |
| Saumur, France, 49403 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Investigator: | Christophe Louvet, MD, PhD | Hopital Saint Antoine |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00075452 History of Changes |
| Other Study ID Numbers: | CDR0000346480, FRE-GERCOR-GEM-GEMOX/D00-3, EU-20324 |
| Study First Received: | January 9, 2004 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms 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 Gemcitabine Oxaliplatin |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013