Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
cisplatin
+ alvocidib
+ cisplatin/flavopiridol
Tumeurs abdominales+24
+ Carcinome épithélial ovarien
+ Maladies génito-urinaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol. II. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are accrued to two separate groups (Group 2 closed to accrual as of 3/10/06) . GROUP 1: Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. GROUP 2 (Closed to accrual as of 3/10/06): Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 3 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.45 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.Femme
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
Inclusion Criteria: * Histologically confirmed ovarian epithelial or primary peritoneal cancer: Advanced disease * Meets at least 1 of the following criteria: * Measurable disease; * Evaluable disease plus CA 125 \>= 2 times post-treatment nadir * Treated with 1, and only 1, prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer * Prior treatment with the same regimen at first relapse allowed; * No more than 3 total chemotherapy regimens allowed provided exactly 1 has been platin-containing; * Must also have platin-resistant disease as defined for Group 1; * Rechallenge with a single regimen upon progression after a hiatus from therapy counts as a single regimen * Group 1, meeting 1 of the following criteria: * Patients who relapse during or \< 6 months after completion of post-debulking chemotherapy; * "Platinum sensitive" patients in second relapse after having been treated/rechallenged with their initial regimen upon first relapse * Group 2 (Closed to accrual as of 3/10/06): * Patients who relapse \>= 6 months after completion of post-debulking chemotherapy and are not retreated with the same or a different regimen * No CNS metastases * Performance status: * ECOG 0-2 * Hematopoietic: * Absolute neutrophil count \>= 1,500/mm3; * Platelet count \>= 100,000/mm3; * Hemoglobin \>= 10 g/dL (Note: May be supported with transfusion, epoetin alfa, or darbepoetin alfa) * Hepatic: * AST =\< 2.5 times upper limit of normal (ULN); * Alkaline phosphatase =\< 2.5 times ULN; * Bilirubin =\< 1.5 times ULN * Renal: * Creatinine =\< 1.5 times ULN * Cardiovascular: * No cardiac arrhythmia; * No cardiac failure * Not pregnant or nursing * Negative pregnancy test * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * More than 3 weeks since prior radiotherapy * Recovered from all prior therapy * Fertile patients must use effective contraception * No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix * No diabetes * No peripheral neuropathy \>= grade 2 * No baseline diarrhea (\>= 4 stools/day) * No uncontrolled infection * No other concurrent uncontrolled serious medical condition * No concurrent routine colony-stimulating factors
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs 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 1 site