NCT00268411

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3 pancreatic-cancer

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
Last Updated

May 27, 2008

Status Verified

May 1, 2007

First QC Date

December 20, 2005

Last Update Submit

May 23, 2008

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreasstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

Secondary Outcomes (2)

  • Clinical benefits and tolerability

  • Progression-free and overall survival

Interventions

gemcitabine hydrochlorideDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

Hopital Duffaut

Avignon, 84902, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Centre Hospitalier de Dreux

Dreux, 28100, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Hopital Saint - Louis

La Rochelle, 17000, France

Location

Hopital Louis Pasteur - Le Coudray

Le Coudray, 28630, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineOxaliplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Christophe Louvet, MD, PhD

    Hopital Saint Antoine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

September 1, 2004

Last Updated

May 27, 2008

Record last verified: 2007-05

Locations

FR(15)