Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	EORTC-30987 CAN-NCIC-BL7, CECOG-EORTC-30987, GAUO-EORTC-30987, GETUG-EORTC-30987, SOGUG-EORTC-30987, SWOG-30987, NCRI-CRUK-BA11, MRC-BA11, NCT00022191, BL7

Objectives

1. Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.
2. Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis
  • T4b, any N OR any T, N2-3 OR M1



• Ineligible for surgery or radiotherapy with curative intent



• Measurable or evaluable disease



• No known CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy)
• At least 4 weeks since prior immunotherapy

Chemotherapy:

• No prior systemic chemotherapy
• At least 4 weeks since prior local intravesical chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No more than 1 prior course of radiotherapy
• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)

Patient Characteristics:

Age:

• 18 and over

Performance status:

• WHO 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.25 times normal
• AST or ALT less than 2.5 times normal

Renal:

• Glomerular filtration rate at least 60 mL/min
• Calcium normal or clinically insignificant

Cardiovascular:

• No clinically significant cardiac arrhythmia
• No congestive heart failure
• No complete bundle branch block
• No New York Heart Association class III or IV heart disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• 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 compliance
• No grade 3 or 4 infection without neutropenia
• No other serious concurrent systemic disorder that would preclude study therapy
• No mental disorder that would preclude study compliance
• No grade II or greater neuropathy
• No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)

Expected Enrollment

A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.

Outline

This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

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

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Bellmunt J, von der Maase H, Mead GM, et al.: Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy: EORTC30987/Intergroup study. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA5030, 242s, 2007.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Joaquim Bellmunt, MD, PhD, Protocol chair		Ph: 34-93-274-6085 Email: jbellmunt@ecodi.net

Groupe D'Etude des Tumeurs Uro-Genitales

Stephane Culine, MD, Protocol chair		Ph: 33-4-6761-3755 Email: stculine@valdorel.fnclcc.fr

National Cancer Research Institute

Michael Leahy, MBChB, FRACP, FRCP, FRC Path, Protocol chair		Ph: 61-8-9431-2886

Central European Cooperative Oncology Group

Christoph Zielinski, MD, Protocol chair		Ph: 43-1-40-400-4445 Email: christoph.zielinski@meduniwien.ac.at

NCIC-Clinical Trials Group

Malcolm Moore, MD, Protocol chair		Ph: 416-946-2263 Email: malcolm.moore@uhn.on.ca

Southwest Oncology Group

David Smith, MD, Protocol chair		Ph: 734-764-2248; 800-865-1125 Email: dcsmith@umich.edu

German Association of Urologic Oncology

Andreas Boehle, MD, Protocol chair(Contact information may not be current)		Ph: 49-451-500-0000 Email: bochle@medinf-mu-luebeck.de

Spanish Oncology Genito-Urinary Group

Jose Baselga, MD, Protocol chair		Ph: 34-93-274-6077

Medical Research Council Clinical Trials Unit

Michael Leahy, MBChB, FRACP, FRCP, FRC Path, Protocol chair		Ph: 61-8-9431-2886

Registry Information
Official Title		Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy
Trial Start Date		2001-05-09
Registered in ClinicalTrials.gov		NCT00022191
Date Submitted to PDQ		2001-06-08
Information Last Verified		2006-09-20
NCI Grant/Contract Number		CA21661, CA32102

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