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Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium Clinical research trials and Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium. Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium  Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
For Condition: transitional cell cancer of the renal pelvis and ureter,Bladder Cancer,Urethral Cancer
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapyregimen is most effective for transitional cell cancer of the urothelium. PURPOSE: Randomizedphase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.
Details: OBJECTIVES: - Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate, carboplatin, and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy. - Compare the toxicity and acute and intermediate (1-2 years) side effects of these regimens in these patients. - Compare the complete response rates, progression-free survival, and overall survival of patients treated with these regimens. - Compare the symptoms and quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. - Arm I: Patients receive methotrexate* IV and vinblastine IV on days 1, 15, and 22 and carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: * Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mL/min or creatinine greater than 2 mg/dL Patients in either arm who achieve a complete response (CR) receive 2 additional courses of chemotherapy beyond CR. Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6 weeks of completion of therapy. Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the phase II portion of this study. A total of 225 patients will be accrued for the phase III portion of this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell cancer of the urothelium, including the renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following criteria: - Unresected positive lymph node - Distant metastases (M1, stage IV) - Unresectable primary bladder cancer (T3-4) - Measurable disease - Ineligible for cisplatin-based chemotherapy and presenting with the following: - WHO performance status 2 AND/OR - Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min - No brain metastases or other CNS lesions PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - See Disease Characteristics Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 125,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times normal - AST/ALT no greater than 3 times normal (5 times normal if liver metastases are present) Renal: - See Disease Characteristics - Calcium normal Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 6 months after study participation - No psychological, familial, sociological, or geographical condition that would preclude study participation - No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior systemic biologic therapy Chemotherapy: - See Disease Characteristics - No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy) Endocrine therapy: - Not specified Radiotherapy: - At least 3 months since prior radiotherapy - Prior radiotherapy to study lesions allowed if there is evidence of disease progression Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GerwinKaiser, Study Chair, Klinikum Nuernberg - Klinikum Nord
Assaf Harofeh Medical Center *Recruiting*
Zerifin, , 70300
Israel
Recruiting Contact Person 972-3-964-8040
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Contact Person 45-3-545-4286
Groot Ziekengasthuis 's-Hertogenbosch *Recruiting*
's-Hertogenbosch, , 5211 NL
Netherlands
Recruiting Contact Person 31-73-611-2446
Universita Di Palermo *Recruiting*
Palermo, , 90145
Italy
Recruiting Contact Person 39-6-255-292
National Institute of Oncology *Recruiting*
Budapest, , 1125
Hungary
Recruiting Contact Person 36-1-355-4411
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-526-911
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
Klinikum Nuernberg - Klinikum Nord *Recruiting*
Nuernberg, , D-90419
Germany
Recruiting Contact Person 49-911-398-2460
Hospital Clinic y Provincial de Barcelona *Recruiting*
Barcelona, , 08036
Spain
Recruiting Contact Person 34-93-227-5400
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting Contact Person 31-20-512-9111
Onze Lieve Vrouw Ziekenhuis Aalst *Recruiting*
Aalst, , B-9300
Belgium
Recruiting Contact Person 32-53-785-353
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Contact Person 34-330-3000
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-332-278-111
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02-781
Poland
Recruiting Contact Person 48-22-546-2169
University Hospital - Rotterdam Dijkzigt *Recruiting*
Rotterdam, , 3000 CA
Netherlands
Recruiting Contact Person 31-10-463-9222
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3584 CX
Netherlands
Recruiting Contact Person 31-30-250-9111
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Contact Person 44-117-923-0000
St. James's University Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Contact Person 44-113-206-4904
Ciudad Sanitaria Vall D'Hebron *Recruiting*
Barcelona, , 08035
Spain
Recruiting Contact Person 34-93-489-3000
Hospsital de Sabadell *Recruiting*
Sabadell, , 08208
Spain
Recruiting Contact Person 34-723-1010
Hospital de la Santa Cruz I Sant Pau *Recruiting*
Barcelona, , 08025
Spain
Recruiting Contact Person 34-3-473-3133
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Contact Person 44-23-8077-7222
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Additional Information:
Study ID Numbers: CDR0000068525; EORTC-GU-30986
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014274
Other Urethral Cancer Studies:
1. Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer
2. Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer
3. Combination Chemotherapy Followed By Observation or Surgery in Treating Patients With Stage II or Stage III Cancer of the Urothelium
4. Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
5. BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer
Related Studies:
Other Urethral Cancer Clinical Trials
Other Clinical Trials
Other Rotterdam Clinical Trials
Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
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