Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00101842
First Posted: January 17, 2005
Last Update Posted: August 29, 2006
Information provided by:
Eli Lilly and Company
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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 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
MedlinePlus related topics:
Bladder Cancer
Drug Information available for:
Cisplatin
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
| 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
| ClinicalTrials.gov Identifier: | NCT00101842 History of Changes |
| Other Study ID Numbers: |
9439 H3E-US-S066 |
| First Submitted: | January 14, 2005 |
| First Posted: | January 17, 2005 |
| Last Update Posted: | August 29, 2006 |
| Last Verified: | August 2006 |
Additional relevant MeSH terms:
|
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 |