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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00101842
First received: January 14, 2005
Last updated: August 24, 2006
Last verified: August 2006
History of Changes
  Purpose

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 Intervention Phase
Carcinoma, Transitional Cell
 Drug: Pemetrexed
Drug: Gemcitabine
Drug: Platinol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Toxicity will be measured by standard grading methods.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 61
Study Start Date: December 2004
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101842

Locations
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00101842     History of Changes
Other Study ID Numbers: 9439, H3E-US-S066
Study First Received: January 14, 2005
Last Updated: August 24, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Pemetrexed
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
Folic Acid Antagonists

ClinicalTrials.gov processed this record on June 13, 2013