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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00101842
Recruitment Status : Completed
First Posted : January 17, 2005
Last Update Posted : August 29, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Drug: Pemetrexed Drug: Gemcitabine Drug: Platinol Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer
Study Start Date : December 2004
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Toxicity will be measured by standard grading methods.

Secondary Outcome Measures :
  1. Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
  2. 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.
  3. Time to progressive disease is defined as time from enrollment to first date of disease progression.
  4. 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.
  5. Survival time is defined as time from enrollment to death from any cause.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101842


Locations
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United States, Texas
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, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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ClinicalTrials.gov Identifier: NCT00101842    
Other Study ID Numbers: 9439
H3E-US-S066
First Posted: January 17, 2005    Key Record Dates
Last Update Posted: August 29, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Pemetrexed
 Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors