Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

Carcinoma, Transitional Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101842
• Other study ID #: 9439
• Secondary ID: H3E-US-S066
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 14, 2005
• Last updated: August 24, 2006
• Start date: December 2004
• Est. completion date: July 2006

Study information

• Verified date: August 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Intervention

Drug:
• Pemetrexed

• Gemcitabine

• Platinol

Locations

Country	Name	City	State
United States	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.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity will be measured by standard grading methods.
Secondary	Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
Secondary	Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.
Secondary	Time to progressive disease is defined as time from enrollment to first date of disease progression.
Secondary	Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.
Secondary	Survival time is defined as time from enrollment to death from any cause.