First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy - Full Text View

Purpose

The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

Condition	Intervention	Phase
Bladder Cancer Transitional Cell Carcinoma Metastasis	Drug: vinflunine and gemcitabine Drug: placebo and gemcitabine	Phase II Phase III

Genetics Home Reference related topics:

bladder cancer

MedlinePlus related topics:

Bladder Cancer Cancer

ChemIDplus related topics:

Cisplatin Gemcitabine hydrochloride Gemcitabine Vinflunine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To compare Progression-Free Survival [ Time Frame: at end of phase II review and end of study (when the number of events is reached) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the response rate [ Time Frame: at end of phase II review and end of study ] [ Designated as safety issue: No ]
To compare Overall Survival [ Time Frame: at end of phase II review and end of study ] [ Designated as safety issue: No ]
To compare disease control rate [ Time Frame: at end of phase II review and end of study ] [ Designated as safety issue: No ]
To estimate the duration of response [ Time Frame: at end of phase II review and end of study ] [ Designated as safety issue: No ]
To estimate time to response [ Time Frame: at end of phase II review and end of study ] [ Designated as safety issue: No ]
To evaluate the safety profile [ Time Frame: at early safety review, end of phase II review and end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	January 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: vinflunine and gemcitabine solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
2: Placebo Comparator	Drug: placebo and gemcitabine solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
- Calculated creatinine clearance ≤60 mL/min: OR
- New York Heart Association Classification Stage III-IV Congestive Heart Failure
Measurable disease documented by imaging with at least one uni-dimensional lesion
Adequate performance status (ECOG 0, 1, or 2)
Men and women ≥18 years of age

Exclusion Criteria:

Patients in whom radiation or surgery is indicated
Current neuropathy ≥ CTCAE grade 3
Prior radiation to ≥ 30% of bone marrow
Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
Prior allergy to any vinca alkaloid

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389155

Show 112 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA183-002
First Received:	October 17, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00389155
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced or metastatic transitional cell carcinoma of the urothelium

Study placed in the following topic categories:

Urinary Bladder Diseases

Urinary Bladder Neoplasms

Urogenital Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Transitional cell carcinoma

Carcinoma

Cisplatin

Urologic Diseases

Neoplasm Metastasis

Gemcitabine

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Bladder neoplasm

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Immunosuppressive Agents

Antiviral Agents

Pharmacologic Actions

Neoplasms

Neoplastic Processes

Neoplasms by Site

Pathologic Processes

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00389155