Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
filgrastim
+ paclitaxel
+ topotecan hydrochloride
Maladies génito-urinaires+10
+ Maladies Génitales
+ Maladies du col de l'utérus
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel. Determine the feasibility and toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 weeks. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 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.25 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.De 18 à 60 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 recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment Measurable disease or evaluable disease PATIENT CHARACTERISTICS: Age: 18 to physiological 60 Performance status: ECOG 0-2 Life expectancy: Greater than 2 months Hematopoietic: WBC greater than 3000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times normal SGOT/SGPT less than 1.5 times normal Renal: BUN less than 1.5 times normal Creatinine less than 1.5 times normal Creatinine clearance greater than 50 mL/min Other: Ineligible for other high priority national or institutional study Not pregnant or nursing HIV negative No prior malignancy except nonmelanoma skin cancer No serious medical or psychiatric illness preventing treatment or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Greater than 4 weeks since prior chemotherapy No greater than 2 prior chemotherapy regimens No prior taxane or camptothecin Endocrine therapy: No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes) Radiotherapy: Greater than 4 weeks since prior radiation therapy No concurrent radiation therapy Surgery: Greater than 4 weeks since prior surgery
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
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, United StatesOuvrir Herbert Irving Comprehensive Cancer Center at Columbia University dans Google Maps