Ovarian Cancer Clinical Trial
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Summary
The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.
Full Description
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.
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
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02155, United States
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