Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Transitional Cell | Drug: Pemetrexed Drug: Gemcitabine Drug: Platinol | Phase 1 Phase 2 |
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 |

- Toxicity will be measured by standard grading methods.
- 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.

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

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
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 |
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 |
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 |
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 |