Neoadjuvant Chemo (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490880
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

The purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with either radical cystectomy or radiotherapy in the treatment of bladder cancer.


Condition Intervention Phase
Bladder Cancer
Drug: gemcitabine
Drug: cisplatin
Procedure: radical cystectomy
Procedure: radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Evaluation of Efficacy and Toxicity of Combined Treatment: Neoadjuvant Chemotherapy (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer Stage T2b-T3 NO/Nx M0

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To evaluate efficacy

Secondary Outcome Measures:
  • To evaluate pathological complete responses
  • To evaluate progression free survival
  • To evaluate overall survival
  • To evaluate time to disease progression
  • To evaluate safety

Enrollment: 2
Study Start Date: November 2003
Study Completion Date: August 2004
  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically proven urothelial carcinoma of the urinary bladder in stage T2b-T3, N0/Nx, M0.
  • Patients must have measurable disease. Response assessment will be evaluated according to RECIST criteria. Measurable lesions with clearly defined margins will be evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy.
  • Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal 20 mm.

Exclusion Criteria:

  • Patients with prior or concomitant malignant diseases (other than appropriately treated basal cell carcinoma of the skin or carcinoma of the cervix)
  • PSA greater than 5.0 ng/mL
  • Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490880

Locations
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw, Poland
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00490880     History of Changes
Other Study ID Numbers: 8193, B9E-MC-S341
Study First Received: June 21, 2007
Last Updated: June 21, 2007
Health Authority: Argentina: Human Research Bioethics Committee

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
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

ClinicalTrials.gov processed this record on April 17, 2014