Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: oxaliplatin; Drug: gemcitabine hydrochloride

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84902
    • Hopital Duffaut
  • Beauvais, France, 60021
    • C.H.G. Beauvais
  • Dijon, France, 21000
    • Hopital Drevon
  • Dreux, France, 28100
    • Centre Hospitalier de Dreux
  • La Roche Sur Yon, France, F-85025
    • Centre Hospitalier departemental
  • La Rochelle, France, 17000
    • Hopital Saint - Louis
  • Le Coudray, France, 28630
    • Hopital Louis Pasteur - Le Coudray
  • Le Mans, France, F-72000
    • Clinique Victor Hugo
  • Lormont, France, 33310
    • Polyclinique des Quatre Pavillons
  • Lyon, France, 69008
    • Clinique Saint Jean
  • Paris, France, 75970
    • Hôpital Tenon
  • Paris, France, 75571
    • Hôpital Saint Antoine
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Reims, France, F-51100
    • Polyclinique de Courlancy
  • Senlis, France, 60309
    • C.H. Senlis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rate

Secondary Outcome Measures

Outcome Measure
Progression-free and overall survival
Clinical benefits and tolerability

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Study Chair: Christophe Louvet, MD, PhD, Hôpital Saint Antoine

Study record dates

Study Major Dates

• Study Start: September 1, 2004

Study Registration Dates

• First Submitted: December 20, 2005
• First Submitted That Met QC Criteria: December 20, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 27, 2008
• Last Update Submitted That Met QC Criteria: May 23, 2008
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: adenocarcinoma of the pancreas; stage IV pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Oxaliplatin
• Other Study ID Numbers: CDR0000453849; GERCOR-D04-1-GEMOX; EU-20569; SANOFI-GERCOR-D04-1-GEMOX