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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Ohio
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Columbus, Ohio, Stati Uniti, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
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Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
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Inizio studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OSU-99H0284
- CDR0000067419 (Identificatore di registro: PDQ (Physician Data Query))
- NCI-T99-0017
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