Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

NCT00014274 | Completed Phase 2

• 2 other identifiers: EORTC-30986EORTC-GU-30986
• Study Type: interventional
• Target: 238
• Locations: 11 countries
• Sites: 29

Brief Summary

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 chemotherapy regimen is most effective for transitional cell cancer of the urothelium. PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Keywords

stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; anterior urethral cancer; posterior urethral cancer; urethral cancer associated with invasive bladder cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter

Outcome Measures

Primary Outcomes (1)

• Duration of survival

Secondary Outcomes (2)

• Response as assessed by RECIST criteria

• Toxicity as assessed by CTC v2

Interventions

carboplatin DRUG

gemcitabine hydrochloride DRUG

methotrexate DRUG

vinblastine sulfate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (29)

St. Johanns-Spital

Salzburg, A-5020, Austria

Location

Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

AZ Groeninge - Oncologisch Centrum

Kortrijk, 8500, Belgium

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Universita Di Palermo

Palermo, 90145, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

Leeds Cancer Centre at St. James's University Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (3)

• De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Gil T, Marreaud S, Daugaard G, Skoneczna I, Collette S, Lorent J, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012 Jan 10;30(2):191-9. doi: 10.1200/JCO.2011.37.3571. Epub 2011 Dec 12.

  PMID: 22162575 RESULT

• De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Skoneczna I, Marreaud S, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: phase II--results of EORTC study 30986. J Clin Oncol. 2009 Nov 20;27(33):5634-9. doi: 10.1200/JCO.2008.21.4924. Epub 2009 Sep 28.

  PMID: 19786668 RESULT

• De Santis M, Bellmunt J, Mead B, et al.: Randomized phase II/III study assessing gemcitabine/carboplatin (GC) and methotrexate/carboplatin/vinblastine (M-CAVI) in previously untreated patients (pts) with advanced urothelial cancer ineligible for cisplatin based chemotherapy: phase II results of. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-288, 2008.

  RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Carboplatin; Gemcitabine; Methotrexate; Vinblastine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Gerwin Kaiser, MD

  Klinikum Nuernberg - Klinikum Nord

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Primary Completion: March 1, 2008
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

DK (1); NL (7); IL (1); IT (2); HU (1); BE (4); AU (2); GB (4); PL (1); DE (1); ES (5)