- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00007917
Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors
A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors.
II. Determine the toxicity and safety profile of this regimen in these patients.
III. Determine the pharmacokinetic profile of this regimen in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists
- Previously untreated disease allowed
- No large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis)
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
- No prior thrombotic events
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No clinically significant cardiac disease
- No prior deep venous thrombus
- No prior arterial vascular event
- No prior myocardial infarction
- No unstable angina
- No prior transient ischemic attack or cerebrovascular accident
- No cardiac arrhythmias that could be related to cardiac ischemia
Pulmonary:
- No clinically significant pulmonary disease
- No history of pulmonary embolism
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No severe malnutrition or intractable emesis
- No chronic diarrheal disease within the past 6 months
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- No more than 1 prior chemotherapy regimen
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior gemcitabine or flavopiridol allowed
- No other concurrent chemotherapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
- No prior radiotherapy to more than 50% of bone marrow
- No concurrent radiotherapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I
Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Gemcitabin
- Alvocidib
Andre studie-ID-numre
- 00-166
- U01CA062490 (U.S. NIH-stipend/kontrakt)
- P30CA006516 (U.S. NIH-stipend/kontrakt)
- DFCI-00166
- NCI-24
- CDR0000068344 (Registeridentifikator: PDQ (Physician Data Query))
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