A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma
Carboplatin
+ Cyclophosphamide
+ Filgrastim
Maladies génito-urinaires+12
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the safety and feasibility of multiple courses of high dose carboplatin, paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma. II. Determine the pathological complete response rate, disease free survival, and overall survival in patients treated with this regimen. OUTLINE: This is a multicenter study. Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2 hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF sub-cutaneously (SQ) daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days. One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found during laparoscopy, then exploratory laparotomy must also be performed. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.
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.12 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 proven optimally debulked stage III ovarian or primary peritoneal carcinoma Any of the following subtypes: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell carcinoma Transitional cell carcinoma Endometrioid adenocarcinoma Undifferentiated adenocarcinoma Mixed epithelial adenocarcinoma Adenocarcinoma, not otherwise specified No ovarian carcinoma of low malignant potential (borderline) Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease No more than 8 weeks since prior surgical debulking Must have Hickman catheter in place or be eligible for placement No CNS involvement Performance status - GOG 0 or 1 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal No active hepatitis Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No renal failure Curatively treated ureteral obstruction allowed if above creatinine measurements met No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmias requiring medication No poorly controlled systolic or diastolic hypertension (diastolic blood pressure consistently greater than 100 mm Hg) No significant nonneoplastic pulmonary disease No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative No other severe medical or psychiatric illness including, but not limited to the following: Acute infection Active peptic ulcer disease Uncontrolled diabetes mellitus Prior hospitalization for psychiatric illness, including severe depression or psychosis Concurrent alcohol or drug abuse No prior chemotherapy for this malignancy No radiotherapy to greater than 25% of bone marrow See Disease Characteristics
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
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
Gynecologic Oncology Group
Philadelphia, United StatesOuvrir Gynecologic Oncology Group dans Google Maps