- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00004173
Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
A Phase I Study of Oxaliplatin in Combination With Paclitaxel
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 oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer.
- Determine the qualitative and quantitative toxicities of this regimen in these patients.
- Determine the therapeutic response to this regimen in these patients.
- Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients.
- Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics, toxicity, and response in these patients.
OUTLINE: This is a dose escalation study.
Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18 months.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically proven metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3000/mm^3
- Absolute neutrophil count at least 1500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- SGOT/SGPT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No neuropathy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No allergy to platinum compounds or antiemetics
- No uncontrolled concurrent illness
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 2 prior chemotherapy regimens
- No prior oxaliplatin or paclitaxel
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- Not specified
Other:
- No other concurrent investigational agents
- No concurrent antiretroviral therapy for HIV (HAART)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OSU-99H0284
- CDR0000067419 (Registry Identifier: PDQ (Physician Data Query))
- NCI-T99-0017
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med oxaliplatin
-
Xijing HospitalUkendt
-
Lin ChenUkendtGastrisk AdenocarcinomKina
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræft | Primær peritoneal kræftForenede Stater, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræftForenede Stater, Canada
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
-
St. Jude Children's Research HospitalNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor i barndommen, protokolspecifikForenede Stater
-
University of California, DavisNational Cancer Institute (NCI)AfsluttetStadie IV brystkræftForenede Stater
-
University of ChicagoNational Cancer Institute (NCI)AfsluttetBlærekræft | Overgangscellekræft i nyrebækkenet og urinlederenForenede Stater, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetEndometriecancerForenede Stater
-
European Organisation for Research and Treatment...AfsluttetBrystkræftFrankrig, Belgien, Slovenien, Israel, Det Forenede Kongerige, Tyskland, Østrig