Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
Amifostine
Maladies génito-urinaires+21
+ Maladies Génitales
+ Maladies du sein
Soins de support
Résumé
Date de début de l'étude : 1 mai 2004
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.24 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 15 sites
CCOP - Carle Cancer Center
Urbana, United StatesCCOP - Wichita
Wichita, United StatesChristus St. Frances Cabrini Center for Cancer Care
Alexandria, United States