Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dana-Farber Cancer Institute
With
Brigham and Women's Hospital
Massachusetts General Hospital
OBJECTIVES:
Primary
•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.
Secondary
* Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients
* Assess significant toxicities in this group of patients and compare to a non-elderly population.
* To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy.
* Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy.
* Assess progression-free survival and overall survival for this group.
* To determine the feasibility of accrual.
STATISTICAL DESIGN:
Using a one sample binomial design, with 37 patients there was 83% power to detect a null hypothesis of a 45% therapy completion rate versus an alternative hypothesis of a 66% rate assuming a one-sided 5% alpha. The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments.
Age
70–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
