Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00268411
• Other study ID #: CDR0000453849
• Secondary ID: GERCOR-D04-1-GEM
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 20, 2005
• Last updated: May 23, 2008
• Start date: September 2004

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
France	Hopital Duffaut	Avignon
France	C.H.G. Beauvais	Beauvais
France	Hopital Drevon	Dijon
France	Centre Hospitalier de Dreux	Dreux
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Hopital Saint - Louis	La Rochelle
France	Hopital Louis Pasteur - Le Coudray	Le Coudray
France	Clinique Victor Hugo	Le Mans
France	Polyclinique des Quatre Pavillons	Lormont
France	Clinique Saint Jean	Lyon
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Polyclinique De Courlancy	Reims
France	C.H. Senlis	Senlis

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate			No
Secondary	Clinical benefits and tolerability			Yes
Secondary	Progression-free and overall survival			No