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Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Transitional Cell

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Trial Information

Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer


Inclusion Criteria:



- Biopsy-proven metastatic bladder cancer

- No prior chemotherapy for metastatic disease except before or after surgery, which
was completed 6 months before enrollment

- Prior radiation allowed, if it is not the only site of measurable disease and if
completed 3 weeks before enrollment

- 18 years of age and older

Exclusion Criteria:

- Pure adeno- or squamous urothelial cancer

- Brain metastases that causes symptoms

- Have not received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication

- Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol

- Clinically relevant fluid collection in the lungs or abdomen that cannot be
controlled

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity will be measured by standard grading methods.

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9439

NCT ID:

NCT00101842

Start Date:

December 2004

Completion Date:

July 2006

Related Keywords:

  • Carcinoma, Transitional Cell
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.San Antonio, Texas