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- Klinische proef NCT00310011
Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
OBJECTIVES:
- Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or local/regional recurrence after cystoprostatectomy.
- Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy.
- Determine response duration, freedom from progression, and overall survival.
- Assess the toxicity of GTP.
OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy (yes vs no).
Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a partial response or complete response undergo surgical restaging and debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28203-4239
- Carolinas Hematology-Oncology Associates
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Greensboro, North Carolina, Verenigde Staten, 27403-1199
- Regional Cancer Center
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Winston-Salem, North Carolina, Verenigde Staten, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements
- No pure squamous cell carcinoma or adenocarcinoma
- Disease not amenable to local curative treatment
Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy
- If regional metastases present alone, histological confirmation of the metastases is required
- No clinically evident brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.6 mg/mL
- Bilirubin ≤ 1.8 mg/mL
- SGOT ≤ 3 times upper limit of normal
- Life expectancy > 3 months
- No known sensitivity to E. coli-derived products
- No other prior or concurrent malignancy except active/inactive nonmelanoma skin cancer, adequately treated stage I or II cancer currently in complete remission, or observation-only early-stage prostate cancer
- No other serious medical illness that would limit survival to < 3 months
- No psychiatric condition that would limit compliance with study requirements
- No active uncontrolled bacterial, viral, or fungal infection unless corrected or controlled
- No hemorrhagic disorder
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy regimen
- Prior intravesical therapy allowed
- Prior definitive radiation to renal pelvis, ureter, or bladder allowed
- No concurrent chemotherapy with nonstudy drugs
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Toxiciteit
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Algemeen overleven
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Reactieduur
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Antwoord
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Vrijheid van progressie
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Frank M. Torti, MD, MPH, Wake Forest University Health Sciences
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urologische neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Nier Ziekten
- Urologische ziekten
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Ziekten van de urineblaas
- Ureterale ziekten
- Nierneoplasmata
- Neoplasmata van de urineblaas
- Carcinoom, overgangscel
- Ureterale neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Gemcitabine
- Paclitaxel
Andere studie-ID-nummers
- CCCWFU-88197
- CDR0000466059 (Register-ID: PDQ (Physician Data Query))
- CCCWFU-BG98-217
- AMGEN-CCCWFU-88197
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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