- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01939483
A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES; I. To evaluate the safety and efficacy of irinotecan (irinotecan hydrochloride) in breast cancer patients with brain metastases who progressed after radiation therapy.
II. To estimate central nervous system (CNS) objective response and clinical benefit rate in patients with breast cancer and brain metastases treated with irinotecan.
III. To estimate progression free survival. IV. To estimate overall survival. V. To assess the toxicity of Irinotecan.
OUTLINE:
Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 24 months.
Tipo di studio
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically confirmed diagnosis of breast cancer (irrespective of receptor status), with evidence of CNS disease by computed tomography (CT) or magnetic resonance imaging (MRI), who have progressed after whole brain radiation therapy or stereotactic radiosurgery
- Patients must not be a candidate for surgical resection and/or further stereotactic radiosurgery
- Patients may have had an unlimited number of prior treatments, including any systemic chemotherapy (excluding prior progression of disease with topoisomerase inhibitors as explained below), surgical resection, whole brain radiation, stereotactic radiosurgery, or radioimmunotherapy
- Patient must have MRI of brain obtained within two weeks of study initiation for staging and patients must also receive first dose within two weeks of study enrollment
- Patients must have at least one measurable brain lesion prior to start of treatment (≥ 10 mm on T1-weighted, gadolinium-enhanced MRI)
- Karnofsky performance score greater than 60
- At least two weeks must have elapsed since prior chemotherapy, three weeks must have elapsed since last surgery, and six weeks since completion of radiation therapy
- Hemoglobin > 9
- Absolute neutrophil count (ANC) > 1500
- Platelet count (plt) > 125
- Creatinine < 1.5
- Total bilirubin < 1.5
- Aspartate aminotransferase and alanine aminotransferase levels within five times the upper limit of normal
- Patients may be on oral corticosteroids at stable dose (no dose change within two weeks of enrollment), and may be on antiepileptic medication (except for cytochrome P450 3A4 (CYP3A4) enzyme-inducing antiepileptic medications)
- Fertile patients must use effective contraception
Exclusion Criteria:
- Pregnancy, lactation, immunosuppression other than corticosteroids
- Patient may be on hormonal therapy or Herceptin, but no other concurrent chemotherapy is allowed
- Patients who had progression of their breast cancer after prior administration of irinotecan are excluded
- Patients with leptomeningeal carcinomatosis as the only site of CNS involvement are excluded
- No other active malignancy except for any of the following: curatively treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, other malignancies considered disease-free
- Patients using valproic acid within the last two weeks and patients with contraindications to anticholinergic agents will be excluded
- Concurrent administration of CYP3A4 enzyme-inducing antiepileptic medications (e.g. phenytoin) will not be allowed (if patients are taking one of these agents, they must switch to a non- enzyme-inducing antiepileptic medication prior to start of treatment)
- No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast, and no other known contraindication to MRI
- Homozygous for uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele * All patients will be tested for UGT1A genotype prior to starting treatment and be excluded if they are homozygous for the UGT1A1*28 allele (UGT1A1 7/7 genotype); irinotecan's active metabolite glucuronidation of 7-ethyl-10-hydroxycamptothecin (SN-38) is inactivated through glucuronidation by uridine diphosphate glucuronosyltransferases (UGTs) mainly in the liver and is excreted through the bile ducts; a meta-analysis demonstrated that the UGT1A1*28 genotype is moderately predictive of severe irinotecan induced hematologic toxicity at moderate doses and strongly predictive at high doses, and in 2005, the Food and Drug Administration (FDA) added a warning to the irinotecan packaging label that patients with the UGT1A1*28 genotype were at increased risk for neutropenia
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)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Treatment (irinotecan hydrochloride)
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. This arm also includes laboratory biomarker analysis as an intervention. |
Studi correlati
Dato IV
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
CNS objective response (complete response or partial response), defined as at least 20% volumetric reduction of CNS lesions in absence of increasing steroid use, progressive neurologic signs and symptoms, or progressive extra-CNS disease, based on MRI
Lasso di tempo: Up to 24 months
|
Up to 24 months
|
Response rate of patients who have remained progression-free, based on MRI
Lasso di tempo: Up to 6 months
|
Up to 6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall survival
Lasso di tempo: Time between treatment initiation and death, assessed up to 24 months
|
The product limit estimator developed by Kaplan and Meier was used to graphically describe the distribution of survival among patients with recurrent disease.
|
Time between treatment initiation and death, assessed up to 24 months
|
Progression free survival (PFS)
Lasso di tempo: Time between treatment initiation and disease progression/relapse/death, assessed up to 24 months
|
The product limit estimator developed by Kaplan and Meier was used to graphically describe the distribution of PFS among patients with recurrent disease.
|
Time between treatment initiation and disease progression/relapse/death, assessed up to 24 months
|
Clinical benefit rate (objective response + stable disease at least 16 weeks)
Lasso di tempo: Up to 24 months
|
Up to 24 months
|
|
Frequency of toxicity occurrence, assessed by National Cancer Institute's Common Terminology Criteria (CTC) for Adverse Events version 4.0
Lasso di tempo: Up to 24 months
|
Tabulated by type, and worst grade experienced by the patient.
Toxicity will initially be summarized within each cohort or patient subgroup, and then collectively summarized.
|
Up to 24 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Rita Mehta, MD, University of California, Irvine
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
- Processi patologici
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Processi neoplastici
- Neoplasie mammarie
- Metastasi neoplastica
- Neoplasie mammarie, maschio
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi
- Inibitori della topoisomerasi I
- Irinotecano
- Camptotecina
Altri numeri di identificazione dello studio
- UCI 11-22
- 2011-8497 (Altro identificatore: University of California, Irvine)
- NCI-2013-01136 (Altro identificatore: NCI Clinical Trials Reporting Program (CTRP))
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 .
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