Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
Collecte de données
Maladies génito-urinaires+13
+ Adénocarcinome
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2006
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin. Secondary * Determine the tolerability of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.
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.22 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
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.De 18 à 120 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: * Histologically confirmed collecting duct renal cell carcinoma * Advanced locally recurrent or metastatic disease * Not amenable to resection * Measurable disease * No active CNS metastases * Patients with CNS metastases previously treated with surgical resection and/or radiotherapy are eligible provided there is no evidence of disease progression by head CT scan or MRI at 3 months after the completion of definitive therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 2 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy greater than grade 1 * No other prior malignancy except for curatively treated cancer from which the patient has been disease-free for the length of time considered appropriate for cure of the specific cancer * No known hypersensitivity to Cremophor EL * No active serious infection * No other serious underlying medical condition that would preclude study therapy * No dementia or significantly altered mental status that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 2 prior biologic response modifier (BRM) regimens * Regimens may have included interleukin-2 and/or interferon alfa * At least 4 weeks since prior BRM therapy Chemotherapy * Not specified Endocrine therapy * Concurrent corticosteroids allowed Radiotherapy * See Disease Characteristics * Prior radiotherapy allowed provided there is measurable disease that has not been irradiated OR there is clear evidence of tumor progression in an irradiated site * At least 4 weeks since prior radiotherapy * No concurrent external beam radiotherapy Surgery * See Disease Characteristics * No concurrent major surgery Other * No other concurrent anticancer drugs
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
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 35 sites
Baptist Cancer Institute - Jacksonville
Jacksonville, United StatesOuvrir Baptist Cancer Institute - Jacksonville dans Google MapsRush-Copley Cancer Care Center
Aurora, United StatesRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesHematology and Oncology Associates
Chicago, United States