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

This study has been completed.
Sponsor:
Collaborators:
Groupe D'Etude des Tumeurs Uro-Genitales
Institute of Cancer Research, United Kingdom
Central European Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
German Association of Urologic Oncology
Spanish Oncology Genito-Urinary Group
Medical Research Council
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00022191
First received: August 10, 2001
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 608
Study Start Date: May 2001
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

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

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

  Eligibility

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • 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)

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022191

  Show 234 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Groupe D'Etude des Tumeurs Uro-Genitales
Institute of Cancer Research, United Kingdom
Central European Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
German Association of Urologic Oncology
Spanish Oncology Genito-Urinary Group
Medical Research Council
Investigators
Study Chair: Joaquim Bellmunt, MD, PhD Vall d'Hebron University Hospital
Study Chair: Stephane Culine, MD Centre Val d'Aurelle - Paul Lamarque
Study Chair: Michael Leahy, MBChB, FRACP, FRCP, FRC Path Fremantle Hospital
Study Chair: Christoph Zielinski, MD Allgemeines Krankenhaus - Universitatskliniken
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
Study Chair: David C. Smith, MD University of Michigan Cancer Center
Study Chair: Andreas Boehle, MD Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Study Chair: Jose Baselga, MD Vall d'Hebron University Hospital
  More Information

Additional Information:
Publications:
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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00022191     History of Changes
Other Study ID Numbers: EORTC-30987, EORTC-30987, CAN-NCIC-BL7, CECOG-EORTC-30987, GAUO-EORTC-30987, GETUG-EORTC-30987, SOGUG-EORTC-30987, SWOG-30987, NCRI-CRUK-BA11, MRC-BA11
Study First Received: August 10, 2001
Last Updated: June 11, 2013
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV bladder cancer
transitional cell carcinoma of the bladder
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Paclitaxel
Gemcitabine
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents

ClinicalTrials.gov processed this record on October 19, 2014