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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00022191




Registration number
NCT00022191
Ethics application status
Date submitted
10/08/2001
Date registered
27/01/2003
Date last updated
12/06/2013

Titles & IDs
Public title
Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Scientific 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
Secondary ID [1] 0 0
EORTC-30987
Secondary ID [2] 0 0
EORTC-30987
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Transitional Cell Cancer of the Renal Pelvis and Ureter 0 0
Urethral Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - gemcitabine hydrochloride
Treatment: Drugs - paclitaxel

Treatment: Drugs: cisplatin


Treatment: Drugs: gemcitabine hydrochloride


Treatment: Drugs: paclitaxel
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Groupe D'Etude des Tumeurs Uro-Genitales
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Institute of Cancer Research, United Kingdom
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Central European Cooperative Oncology Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
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NCIC Clinical Trials Group
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Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
SWOG Cancer Research Network
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Other collaborator category [7] 0 0
Other
Name [7] 0 0
German Association of Urologic Oncology
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Other collaborator category [8] 0 0
Other
Name [8] 0 0
Spanish Oncology Genito-Urinary Group
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Medical Research Council
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00022191
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joaquim Bellmunt, MD, PhD
Address 0 0
Vall d'Hebron University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00022191