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Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192712
First received: September 11, 2005
Last updated: November 9, 2010
Last verified: September 2010
History of Changes
  Purpose

The study hypothesis is that chemoradiation based on 2 drugs will improve local control and long-term survival in patients with locally advanced pancreatic cancer. That is why gemcitabine and irinotecan are combined in an induction phase of 2 months and then this IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with irradiation.


Condition Intervention Phase
Pancreatic Cancer
 Drug: irinotecan, gemcitabine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • time to treatment failure

Secondary Outcome Measures:
  • response rate, survival, toxicity

Estimated Enrollment: 20
Study Start Date: November 2002
Study Completion Date: September 2010
  Eligibility

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

Inclusion Criteria:

  • locally advanced pancreatic cancer
  • performance status 0-2
  • normal blood count and chemistry
  • no previous chemotherapy or radiotherapy

Exclusion Criteria:

  • serious concurrent systemic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192712

Locations
Israel
Department of Oncology, Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ron Epelbaum, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192712     History of Changes
Other Study ID Numbers: RonIrinoGem.CTIL
Study First Received: September 11, 2005
Last Updated: November 9, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
carcinoma
pancreas
chemotherapy
radiotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013