- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00016185
Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
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.
PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in treating patients who have advanced solid tumors.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
OBJECTIVES:
- Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol and docetaxel in patients with advanced solid tumors.
- Determine the objective response rate and duration of response in patients treated with this regimen.
- Determine the pharmacokinetics of these drugs in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over 24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 9-11 months.
Typ studie
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
-
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Michigan
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Detroit, Michigan, Spojené státy, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic or unresectable solid tumor
- No standard relatively effective curative or palliative measures exist
Measurable disease in at least 1 dimension
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No known clinically active and uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
- Karnofsky 60-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- ALT/AST no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine normal
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No prior allergic reactions to compounds of similar chemical or biologic composition to flavopiridol or docetaxel
- No other uncontrolled concurrent illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- At least 6 months since prior taxane therapy
- At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except contraceptives, appetite stimulants, or replacement steroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Philip A. Philip, MD, PhD, FRCP, Barbara Ann Karmanos Cancer Institute
Publikace a užitečné odkazy
Obecné publikace
- El-Rayes BF, Gadgeel S, Parchment R, Lorusso P, Philip PA. A phase I study of flavopiridol and docetaxel. Invest New Drugs. 2006 Jul;24(4):305-10. doi: 10.1007/s10637-005-4343-5.
- Patel B, El-Rayes BF, Gadgeel SM, et al.: A phase I study of flavopiridol and docetaxel. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-932, 2003.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CDR0000068605
- P30CA022453 (Grant/smlouva NIH USA)
- WSU-C-2197
- NCI-1610
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