Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer - Full Text View

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:

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

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


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, 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

ClinicalTrials.gov processed this record on September 30, 2016