Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008138
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2001-01-06
Brief Title:
S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S0009
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0009 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |