A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients
taxol
Maladies génito-urinaires+12
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1991
Date à laquelle le premier participant a commencé l'étude.This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.
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.60 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.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
All patients must have biopsy proven ovarian cancer as determined by evaluation in the Laboratory of Pathology, NCI. Germ cell and borderline histologies are specifically excluded. Patients must have FIGO stage III and IV disease, or FIGO Stage IIC disease with poorly differentiated histology, and will undergo attempted surgical debulking prior to the initiation of chemotherapy. Prior chemotherapy or radiation therapy will make a patient ineligible. Performance status: less than or equal to ECOG 2. Patients must have the following end organ function: No brain involvement. No history of myocardial infarction, cardiac arrhythmias requiring therapy, right bundle branch block with left anterior hemiblock, and left bundle branch block. Renal function: creatinine clearance greater than or equal to 60 cc/min; patients with ureteral obstruction must have this corrected prior to starting therapy. Hepatic function: normal coagulation parameters, serum transaminases within 3 times upper limit of normal. Neurologic function: no preexisting dysfunction greater than grade 1 (exclusive of mild vibratory delay). No recent history of active GI bleeding. Hematologic parameters prior to starting cycle 1 of therapy: total granulocyte count greater than 2000 and platelet count greater than 100,000. Patients may not have had prior history of invasive malignancy with the exception of nonmelanoma skin cancer curatively treated. Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol. Patients must be able to begin therapy within 8 weeks of staging laparotomy and should have a central venous catheter placed for infusion of chemotherapy. All patients must be registered by calling the Orkand Corporation at 402-1732 between the hours of 8:30 AM and 5:00 PM; eligibility criteria will be queried.
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
National Cancer Institute (NCI)
Bethesda, United StatesOuvrir National Cancer Institute (NCI) dans Google Maps