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Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00551096
First received: October 26, 2007
Last updated: July 2, 2009
Last verified: July 2009
History of Changes
  Purpose

Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose of the combination has been determined, additional patients with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or metastatic pancreatic cancer will be treated at the highest determined dose for further studies.


Condition Intervention Phase
Advanced Solid Tumors
Biliary Cancer
Pancreatic Cancer
 Drug: Gemcitabine, capecitabine and ZD6474 (Zactima)
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Estimated Enrollment: 28
Study Start Date: October 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine, capecitabine and ZD6474 (Zactima)

    Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2. Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off .

    ZACTIMA haadministered orally at 300 mg/day once daily. One cycle will consist of 28 days.

  Eligibility

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

Inclusion Criteria:

  • Age 18 years or older
  • ECOG performance status of 0-1 (measure of your ability to perform everyday tasks)
  • Life expectancy of at least three months

Blood samples and other testing may apply for further testing of eligibility.

Exclusion Criteria:

  • Uncontrolled illness (for example, current infections or heart conditions)
  • Abnormal laboratory tests (such as blood or urine testing)
  • Pregnant or breastfeeding women

Further exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551096

Contacts
Contact: Stephen Leong, MD 303-724-3837 stephen.leong@ucdenver.edu
Contact: Sarah Eppers 720-848-0052 sarah.eppers@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Stephen Leong, MD     303-724-3837     stephen.leong@ucdenver.edu    
Contact: Sarah Eppers     720-848-0052     sarah.eppers@ucdenver.edu    
Principal Investigator: Stephen Leong, MD            
Sponsors and Collaborators
University of Colorado, Denver
AstraZeneca
Investigators
Principal Investigator: Stephen Leong, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Stephen Leong, MD, University of Colorado Denver
ClinicalTrials.gov Identifier: NCT00551096     History of Changes
Other Study ID Numbers: 07-0129
Study First Received: October 26, 2007
Last Updated: July 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Advanced Solid Tumors with an Expanded Cohort of Patients with Biliary or Pancreatic Malignancies

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract 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