Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191568

Purpose

A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Neoplasms	Drug: Gemcitabine Drug: Oxaliplatin Procedure: Radiotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study

Secondary Outcome Measures:

To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)

Estimated Enrollment:	45
Study Start Date:	October 2002
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically confirmed adenocarcinoma of the pancreas
Patient have undergone a potentially curative resection
No previous irradiation to the planned field
Negative pregnancy test for child bearing women

Exclusion Criteria:

Non-adenocarcinoma pancreatic cancer
Treatment with any drug within the last 30 days that has not received regulatory approval.
Serious systemic disorder
Metastatic disease
Pregnancy, breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191568

Locations

France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
PIERRE BENITE, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Paris, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Grenoble, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Lyon, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Montpellier, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Marseille, France

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	6866, B9E-MC-S298
Study First Received:	September 12, 2005
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00191568 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Adjuvants, Immunologic
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents

Oxaliplatin
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009