- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00003760
Irofulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer
A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.
Panoramica dello studio
Descrizione dettagliata
OBJECTIVES: I. Determine the survival rate at 6 months of patients with stage III or IV unresectable adenocarcinoma of the pancreas treated with 6-hydroxymethylacylfulvene (MGI 114). II. Determine the objective tumor response rate, time to objective tumor response, and duration of response in these patients (if retrospective data is available, time to tumor progression while on prior gemcitabine is determined). III. Determine the clinical benefit of MGI 114 as measured by pain improvement, performance status, and weight. IV. Determine the survival rate at 3, 9, and 12 months in these patients. V. Gain additional information on the toxic effects and safety profile of this regimen.
OUTLINE: This is an open label, multicenter study. Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12-18 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198-3330
- University of Nebraska Medical Center
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Texas
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Fort Sam Houston, Texas, Stati Uniti, 78234
- Brooke Army Medical Center
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San Antonio, Texas, Stati Uniti, 78229
- San Antonio Cancer Institute
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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 or cytologically confirmed stage III or IV unresectable adenocarcinoma of the exocrine pancreas Must have been treated with 1 prior gemcitabine regimen, and have documented disease progression either during or within 6 months after completion of therapy Measurable or evaluable disease outside of previously irradiated area No islet cell tumors or lymphoma of the pancreas No significant CNS disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No atrial or ventricular arrhythmias requiring medication No atrial fibrillation (with or without medication) No ischemic event within past 6 months No history of congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No significant psychiatric disorders No active infection No other prior malignancies within past 5 years, except: Basal or squamous cell skin cancer Carcinoma in situ of the cervix No concurrent serious systemic disorder
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior gemcitabine therapy and recovered No other prior chemotherapy (except fluorouracil as a radiation enhancing agent) No other concurrent chemotherapy Endocrine therapy: No prior hormonal therapy No concurrent hormonal therapy (except contraceptives, hormone replacement, or megestrol acetate) Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational agents
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Eric K. Rowinsky, MD, San Antonio Cancer Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Malattie del sistema endocrino
- Neoplasie dell'apparato digerente
- Neoplasie delle ghiandole endocrine
- Malattie pancreatiche
- Neoplasie pancreatiche
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Irofulven
Altri numeri di identificazione dello studio
- CDR0000066884
- P30CA054174 (Sovvenzione/contratto NIH degli Stati Uniti)
- UTHSC-9895011082 (Altro identificatore: UTHSCSA IRB)
- MGI-114.27.P98-03 (Altro identificatore: Merck)
- SACI-IDD-98-18 (Altro identificatore: San Antonio Cancer Institute)
- NCI-V99-1517 (Altro identificatore: NCI)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .