Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer - Full Text View

Sponsored by:	National Research Council, Italy
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054626

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer.

PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder.

Condition	Intervention	Phase
Bladder Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Surgery

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival at 5 years [ Designated as safety issue: No ]
Local disease-free survival at 5 years [ Designated as safety issue: No ]
Distant disease-free survival at 5 years [ Designated as safety issue: No ]
Toxicity by WHO system grading after each course [ Designated as safety issue: Yes ]
Quality of life after each course and every 6 months during follow-up [ Designated as safety issue: No ]
Dose intensity at the end of the treatment [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	September 2001
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the overall, cause-specific, and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy.
Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients.
Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease status (T2 [G3 only] or T3-4 [any G], N0-2 vs any T, N1-2, M0). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients are further randomized to 1 of 2 treatment regimens.
- Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15.
- Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A.

Treatment in both regimens repeats every 28 days for 4 courses.

Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed transitional cell carcinoma of the bladder
- T2 (G3 only) or T3-4 (any G), N0-2 or any T, N1-2, M0
- No secondary localization
Radical cystectomy (without residual disease) performed within 10 weeks prior to study entry to include:
- Men: Cystectomy with removal of prostate and seminal vesicles including 1.5 cm of urethra plus pelvic lymphadenectomy (at least 15 negative lymph nodes are recommended to define as N0)
- Women: Cystectomy with complete removal of the bladder, uterus, ovaries, and anterior walls of the vagina plus pelvic lymphadenectomy

PATIENT CHARACTERISTICS:

Age

18 to 74

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm^3
Absolute neutrophil count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic

Bilirubin less than upper normal limit (ULN)
Gamma-GT less than ULN
SGOT and SGPT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN

Renal

Creatinine no greater than1.25 times ULN
Creatinine clearance at least 60 mL/min

Cardiovascular

No congestive heart failure
No angina pectoris
No cardiac arrhythmia
No uncontrolled arterial hypertension
No history of acute myocardial infarction within the past year

Other

No other serious concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior systemic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Palliative radiotherapy allowed at relapse for symptomatic bone metastases

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054626

Show 151 Study Locations

Sponsors and Collaborators

National Research Council, Italy

Investigators

Study Chair:

Camillo F. Pollera, MD

Presidio Ospedaliero Belcolle

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Pollera CF, Merendino N, Cianciulli AM, et al.: Preliminary cytogenetic and pharmacogenomic analysis of muscle-invasive transitional-cell carcinoma (TCC) of the bladder in patients (pts) enrolled in the Italian National Research Council (CNR) phase III randomized trial comparing adjuvant cisplatin-gemcitabine (PG) vs observation (OBS) after radical cystectomy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4589, 400s, 2005.

Study ID Numbers:	CDR0000258426, ITNRC-CU02.00447ST/97, NCI-V02-1715
Study First Received:	February 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00054626 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Urinary Tract Neoplasm
Cystocele
Immunologic Factors
Urinary Bladder Diseases
Adjuvants, Immunologic
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell

Urologic Neoplasms
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Radiation-Sensitizing Agents
Urologic Diseases
Cisplatin
Bladder Neoplasm
Gemcitabine
Transitional Cell Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Urogenital Neoplasms

Urologic Neoplasms
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Urologic Diseases
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine

ClinicalTrials.gov processed this record on September 10, 2009