Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
| 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 II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX] |
- Objective response rate [ Designated as safety issue: No ]
- Clinical benefits and tolerability [ Designated as safety issue: Yes ]
- Progression-free and overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2004 |
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
Secondary
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
Measurable disease (primary tumor or metastasis)
- At least 1 cm in diameter by spiral CT scan
- No ampulla of Vater carcinoma or biliary adenocarcinoma
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy more than 12 weeks
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase < 5 times normal
- Bilirubin < 1.5 times normal
- Creatinine < 1.5 times normal
- No pre-existing neuropathy
- No unstable or uncontrolled pain
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No serious cardiovascular disease
- No serious respiratory disease
- No uncontrolled or persistent hypercalcemia
- No psychological, familial, social, or geographical condition that would preclude study treatment
- No other active malignancy
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No concurrent corticosteroids
Contacts and Locations| France | |
| Hopital Duffaut | |
| Avignon, France, 84902 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Centre Hospitalier de Dreux | |
| Dreux, France, 28100 | |
| Centre Hospitalier Departemental | |
| La Roche Sur Yon, France, F-85025 | |
| Hopital Saint - Louis | |
| La Rochelle, France, 17000 | |
| Hopital Louis Pasteur - Le Coudray | |
| Le Coudray, France, 28630 | |
| Clinique Victor Hugo | |
| Le Mans, France, F-72000 | |
| Polyclinique des Quatre Pavillons | |
| Lormont, France, 33310 | |
| Clinique Saint Jean | |
| Lyon, France, 69008 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Study Chair: | Christophe Louvet, MD, PhD | Hopital Saint Antoine |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00268411 History of Changes |
| Other Study ID Numbers: | CDR0000453849, GERCOR-D04-1-GEMOX, EU-20569, SANOFI-GERCOR-D04-1-GEMOX |
| Study First Received: | December 20, 2005 |
| Last Updated: | May 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms 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 23, 2013