Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
Amifostine
Enfermedades Urogenitales+18
+ Enfermedades de la Mama
+ Neoplasias de la Mama
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the percentage of patients with solid tumors who have persistent paclitaxel-induced peripheral neuropathy who benefit, defined as a decrease of at least 20% on their FUNCTIONAL ASSESSMENT OF CANCER THERAPY/ GYNECOLOGIC ONCOLOGY GROUP NEUROTOXICITY (FACT/GOG-Ntx) FACT-GOG-NTX score, from treatment with subcutaneous amifostine. * Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study. Secondary * Compare the acute toxic effects of this drug administered subcutaneously in these patients vs IV administrations of this drug historically and/or during the GOG-0192 study. * Determine the capability of the Weinstein Enhanced Sensory Test to provide objective, quantitative evidence for improvement in patients who have subjective improvement as self-reported on the FACT-GOG-NTX scale. * Determine whether any benefit in patients treated with this drug is transient or lasts at least 8 weeks. OUTLINE: This is an open-label, multicenter study. Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of symptom progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 4 weeks of therapy. Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at baseline, weekly during therapy, and at 12 weeks and the Weinstein Enhanced Sensory Test administered at baseline and at 4, 8, and 12 weeks. Patients are followed at 12 weeks. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-20 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Diagnosis of a solid tumor, including, but not limited to the following: * Ovarian cancer * Lung cancer * Prostate cancer * Breast cancer * Previously treated with paclitaxel * Peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) believed to be caused by paclitaxel only or the combination of paclitaxel and carboplatin * At least 18 out of 44 on the FACT-GOG-NTX scale * Persistent neuropathy for at least 2, but no more than 12 months after chemotherapy * Not improving * No other possible cause of neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * Karnofsky 50-100% Life expectancy * More than 2 months Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL * Calcium ≥ lower limit of normal Cardiovascular * See Disease Characteristics * No prior cerebrovascular accident Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other significant comorbid medical condition that would preclude study participation * No known sensitivity to aminothiol compounds PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior cisplatin * No chemotherapy during and for at least 3 months after study participation Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No concurrent monoamine oxidase inhibitors
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 15 ubicaciones
CCOP - Carle Cancer Center
Urbana, United StatesCCOP - Wichita
Wichita, United StatesChristus St. Frances Cabrini Center for Cancer Care
Alexandria, United States