Phase I trial of concomitant vinorelbine, cisplatin, and pelvic irradiation in cervical carcinoma and other advanced pelvic malignancies.
Gynecol Oncol
; 92(3): 801-5, 2004 Mar.
Article
en En
| MEDLINE
| ID: mdl-14984944
ABSTRACT
OBJECTIVE:
To determine the maximum tolerated dose (MTD) of vinorelbine in combination with weekly cisplatin and pelvic radiation therapy (RT).METHODS:
Eligible patients included those with bulky or locally advanced cervical cancer. Women with other advanced gynecologic malignancies were also eligible. All patients received cisplatin 40 mg/m(-2)/week (maximum dose, 70 mg) during pelvic RT. Vinorelbine was administered on the same day as cisplatin at a starting dose of 10 mg/m(-2)/week and escalated in 5 mg/m(-2)/week increments. Dose-limiting toxicity (DLT) was defined as grade 3-4 non-hematologic toxicity, grade 4 hematologic toxicity, or any toxicity which required > or =1 week delay in RT or an omission of >1 dose of chemotherapy.RESULTS:
Between April 2001 and September 2002, 12 women with pelvic malignancies (11 cervical, 1 recurrent ovarian) were enrolled. Cohorts of 3, 6, and 3 patients were treated at 10, 15, and 20 mg/m(-2)/week dose levels of vinorelbine. At the 20 mg/m2 level, DLT was observed. Two of three patients missed >1 cycle of chemotherapy secondary to predominantly hematologic toxicity. One patient at the 20 mg level developed a creatinine clearance <50 ml/min and missed 1 dose of cisplatin. Another developed transient grade 3 diarrhea. No grade 4 toxicities were observed.CONCLUSIONS:
The MTD of vinorelbine in combination with cisplatin and pelvic RT in patients with cervical cancer is 15 mg/m(-2)/week.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Neoplasias Pélvicas
/
Vinblastina
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Neoplasias del Cuello Uterino
Límite:
Adult
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
Gynecol Oncol
Año:
2004
Tipo del documento:
Article
País de afiliación:
Estados Unidos