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

August 24, 2006 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

61

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity will be measured by standard grading methods.

Secondary Outcome Measures

Outcome Measure
Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
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.
Time to progressive disease is defined as time from enrollment to first date of disease progression.
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.
Survival time is defined as time from enrollment to death from any cause.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

January 14, 2005

First Submitted That Met QC Criteria

January 14, 2005

First Posted (Estimate)

January 17, 2005

Study Record Updates

Last Update Posted (Estimate)

August 29, 2006

Last Update Submitted That Met QC Criteria

August 24, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9439
  • H3E-US-S066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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