Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00246974

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride ZD1839

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
1: Active Comparator Cisplatin + Gemcitabin	Drug: Gemcitabine intravenous Drug: Cisplatin intravenous
2: Experimental Cisplatin + Gemcitabin + Gefitinib	Drug: Gemcitabine intravenous Drug: Cisplatin intravenous Drug: Gefitinib oral

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
Augsburg, Germany
Research Site
Hamburg, Germany
Research Site
Kassel, Germany
Research Site
Münster, Germany
Research Site
Ulm, Germany
Research Site
Tübingen, Germany
Research Site
Dresden, Germany
Research Site
Mainz, Germany
Research Site
Aachen, Germany
Research Site
Halle/ Saale, Germany
Research Site
Berlin, Germany
Research Site
Mannheim, Germany
Research Site
Freiburg, Germany
Research Site
Hannover, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Iressa Medical Science Director, MD

AstraZeneca

More Information

No publications provided

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

Keywords provided by AstraZeneca:

bladder cancer
Transitionel cell cancer of the urothelium

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Urinary Tract Neoplasm
Cystocele
Immunologic Factors
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Immunosuppressive Agents

Antiviral Agents
Carcinoma
Radiation-Sensitizing Agents
Cisplatin
Urologic Diseases
Bladder Neoplasm
Gemcitabine
Gefitinib
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Cisplatin
Urologic Diseases

Therapeutic Uses
Gemcitabine
Neoplasms by Histologic Type
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009