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Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00316420
First received: April 18, 2006
Last updated: March 4, 2010
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
 Drug: Capecitabine (Xeloda)
Drug: Gemcitabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • MTD and DLT for the combination therapy of gemcitabine and capecitabine [ Time Frame: January 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor Response [ Time Frame: January 2010 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2003
Study Completion Date: August 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine (Xeloda)
    650 mg/m2 po bid Days 1-14 750 mg/m2 po bid Days 1-14 850 mg/m2 po bid Days 1-14 950 mg/m2 po bid Days 1-14
    Other Name: Xeloda
    Drug: Gemcitabine
    750 mg/m2 IV Days 1 & 8 q 21 days
    Other Name: Gemzar
  Eligibility

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

Inclusion Criteria:

  • Metastatic or unresectable pancreatic cancer
  • No prior chemotherapy except radiation-sensitizing doses of 5-FU
  • No radiotherapy less than 4 weeks prior to the start of the study

Exclusion Criteria:

  • Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
  • Moderate to severe renal impairment
  • Uncontrolled diabetes
  • Inability to swallow tablets
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316420

Locations
United States, Washington
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Roche Pharma AG
Investigators
Principal Investigator: Philip Gold, MD Swedish Medical Center Cancer Institute
Principal Investigator: Henry Kaplan, MD Swedish Medical Center Cancer Institute
  More Information

No publications provided

Responsible Party: Philip Gold, M.D., Swedish Medical Center, Swedish Cancer Insitute
ClinicalTrials.gov Identifier: NCT00316420     History of Changes
Other Study ID Numbers: TI027 PG/HK
Study First Received: April 18, 2006
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

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
Capecitabine
Fluorouracil
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

ClinicalTrials.gov processed this record on May 16, 2013