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Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00268411
First received: December 20, 2005
Last updated: May 23, 2008
Last verified: May 2007

December 20, 2005
May 23, 2008
September 2004
Not Provided
Objective response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00268411 on ClinicalTrials.gov Archive Site
  • Clinical benefits and tolerability [ Designated as safety issue: Yes ]
  • Progression-free and overall survival [ Designated as safety issue: No ]
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00268411
CDR0000453849, GERCOR-D04-1-GEMOX, EU-20569, SANOFI-GERCOR-D04-1-GEMOX
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Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Not Provided
Study Chair: Christophe Louvet, MD, PhD Hopital Saint Antoine
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP