Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
- Evaluate the overall survival and progression-free survival in patients with stage III
or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant
paclitaxel and carboplatin.
- Estimate the percentage of these patients whose disease is successfully cytoreduced to
less than 1 cm in diameter following neoadjuvant chemotherapy.
- Evaluate the toxicity of this regimen in these patients.
- Explore the relationship between tumor p53 expression, proliferation rate as measured
by proliferating cell nuclear antigen and apoptotic rate, and human tumor cloning assay
results at time of debulking surgery with progression-free survival and overall
survival in these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant therapy comprising paclitaxel IV over 3 hours followed by
carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in
the absence of disease progression or unacceptable toxicity. Within 35 days of receiving the
third course of chemotherapy, patients with at least a 50% reduction in CA 125 undergo
debulking surgery. Within 35 days of undergoing surgery, patients with a tumor reduction to
below 1 cm receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by
carboplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats
every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually for up to 5 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
assessed ever 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
Amy D. Tiersten, MD
New York University School of Medicine
United States: Federal Government