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Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00246974
First received: October 31, 2005
Last updated: October 14, 2008
Last verified: October 2008
History of Changes
  Purpose

The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.


Condition Intervention Phase
Bladder Cancer
 Drug: Gemcitabine
Drug: Cisplatin
Drug: Gefitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to progression (TTP)

Secondary Outcome Measures:
  • 1. Response rate
  • 2. Overall survival time
  • 3. Time to treatment failure
  • 4. Disease control rate
  • 5. Duration of response
  • 6. Safety and tolerability

Estimated Enrollment: 125
Study Start Date: May 2003
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cisplatin + Gemcitabin
 Drug: Gemcitabine
intravenous
Drug: Cisplatin
intravenous
Experimental: 2
Cisplatin + Gemcitabin + Gefitinib
 Drug: Gemcitabine
intravenous
Drug: Cisplatin
intravenous
Drug: Gefitinib
oral
Other Names:
  • Iressa
  • ZD1839

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
  • Locally advanced or metastatic disease
  • At least one measurable lesion as defined by RECIST
  • Chemotherapy-naiv

Exclusion Criteria:

  • Previous chemotherapy or other systemic antitumour therapy
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246974

Locations
Germany
Research Site
Aachen, Germany
Research Site
Augsburg, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Freiburg, Germany
Research Site
Halle/ Saale, Germany
Research Site
Hamburg, Germany
Research Site
Hannover, Germany
Research Site
Kassel, Germany
Research Site
Mainz, Germany
Research Site
Mannheim, Germany
Research Site
Münster, Germany
Research Site
Tübingen, Germany
Research Site
Ulm, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00246974     History of Changes
Other Study ID Numbers: 1839IL/0063, D7913L00063
Study First Received: October 31, 2005
Last Updated: October 14, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
bladder cancer
Transitionel cell cancer of the urothelium

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Gefitinib
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013