Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring carboplatin, paclitaxel, elderly women
Eligibility Criteria
Inclusion Criteria: Age 70 or older Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus Life expectancy greater than 6 months Baseline laboratory values as described in protocol Exclusion Criteria: Active infection requiring antibiotics at the time of starting chemotherapy Prior pelvic radiotherapy > 25% of bone marrow Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs Past history of bone marrow transplantation or stem cell support Known history of central nervous system (CNS) metastasis History of prior malignancy that required prior systemic therapy Clinically significant cardiac disease Uncontrolled diabetes mellitus Any signs of intestinal obstruction Participation in an investigational drug study within three weeks prior to study entry History of psychiatric disability or other central nervous system disorder
Sites / Locations
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Experimental
Carboplatin/Paclitaxel
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.