Clinical trial NCT00008138
Conditions: Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer
Keywords: stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma fallopian tube cancer peritoneal cavity cancer
Sponsor: SWOG Cancer Research Network
Start date: 2001-03-01; Completion date: 2009-11-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Detailed description:
OBJECTIVES:

* 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.

Arms: arm 1: neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
Interventions: intervention 1: carboplatin intervention 2: paclitaxel intervention 3: debulking surgery
Intervention descriptions: intervention 1: pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles intervention 2: pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles intervention 3: exploratory laparotomy, interval cytoreduction (to \< 1 cm residual)

Protocol documents: