Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)
Fluorouracil
+ Pharmacological Study
+ Suramin
Carcinoma+11
+ Enfermedades Urogenitales
+ Adenocarcinoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2004
Fecha en la que se inscribió al primer participante.PRIMARY OBJECTIVES: I. Determine the dose of suramin and fluorouracil that would result in plasma concentrations of suramin between 10-50 uM in patients with metastatic renal cell cancer. (Phase I) II. Determine the objective response rate (complete response and partial response) in patients treated with this regimen. (Phase II) SECONDARY OBJECTIVES: I. Determine the preliminary efficacy of this regimen in these patients. (Phase I) II. Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) III. Determine the time to tumor progression and progress rate at 3 and 6 months in patients treated with this regimen. (Phase II) OUTLINE: This is a dose-escalation phase I study followed by a phase II study. PHASE I: Patients receive suramin IV over 30 minutes and fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Cohorts of 3-6 patients receive escalating doses suramin and fluorouracil until the dose level allowing 10-50 uM of suramin into the patient's blood is determined without 2 or more of 6 patients experiencing dose-limiting toxicity. PHASE II: Patients receive suramin and fluorouracil (at the dose level determined in phase I) as in phase I. In both phases, courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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
Inclusion Criteria: * Histologically confirmed renal cell cancer * Metastatic disease * Measurable or evaluable disease * Measurable disease required for phase II * No untreated CNS metastasis or CNS metastases progressing ≤ 4 weeks after prior radiotherapy * Performance status - ECOG 0-1 * At least 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * AST ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 5 times ULN * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.8 mg/dL * Calcium ≤ ULN * No untreated hypercalcemia * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must be surgically sterile or use effective contraception * No uncontrolled diabetes mellitus * No known severe hypersensitivity to suramin * No other concurrent uncontrolled illness * No active or ongoing infection * No active autoimmune disease * No neuropathy ≥ grade 2 * No psychiatric illness or social situation that would preclude study compliance * No other malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or localized prostate cancer * No concurrent filgrastim (G-CSF) * No more than 2 prior chemotherapy regimens for renal cell cancer (phase II only) * No concurrent corticosteroid dose more than physiologic replacement levels * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy * Recovered from prior oncologic or other major surgery * At least 4 weeks since prior major surgery * No concurrent surgery * Recovered from all prior anticancer therapy other than alopecia (chronic toxicity \< grade 2) * At least 4 weeks since prior systemic therapy * More than 30 days since prior investigational drugs * Concurrent bisphosphonates allowed
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
Objetivos Secundarios
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 una ubicación