Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331422
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2006-05-30
Brief Title:
Carboplatin Paclitaxel and Surgery in Treating Patients With Advanced Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cavity Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
A Phase II Study of Carboplatin and Paclitaxel as Neoadjuvant Chemotherapy Followed by Interval Cytoreduction in Women With Advanced Staged Epithelial Ovarian Fallopian Tube and Primary Peritoneal Carcinoma for High-Risk Surgical Candidates or Patients Unlikely to be Optimally Surgically Cytoreduced
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to lack of available funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or stopping them from dividing Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin before surgery works in treating patients with advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin before surgery works in treating patients with advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether at least 50 of patients with advanced ovarian epithelial fallopian tube or primary peritoneal cavity cancer are able to achieve optimal cytoreduction to 1 centimeter of remaining disease after neoadjuvant chemotherapy comprising paclitaxel and carboplatin
Secondary
Determine the frequency and severity of toxicity associated with this regimen in patients who are high-risk surgical candidates or in patients unlikely to achieve optimal surgical cytoreduction
Determine if extreme drug resistance assay profiles change after neoadjuvant chemotherapy
Determine how thrombospondin-1 TSP-1 tumor protein 53 p53 and tumor vessel density change after administration of neoadjuvant chemotherapy
Assess the quality of life of patients receiving neoadjuvant chemotherapy
Obtain estimates of tumor response after administration of neoadjuvant chemotherapy
Determine whether serum cancer antigen 125 CA-125 at the time of cytoreduction is associated with the ability to optimally reduce the patients
OUTLINE This is an open-label study
Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Within 4-6 weeks after the fourth course of chemotherapy patients undergo interval cytoreductive surgery
Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and are re-evaluated for surgery after the sixth course of chemotherapy
Within 4 weeks after surgery patients receive 2 additional courses of chemotherapy
Quality of life is assessed periodically
Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning chemotherapy and during interval cytoreduction Tissue is examined by immunohistochemistry staining for p53 TSP-1 microvessel density CD31 angiogenesis membrane protein BCL-2 and multidrug resistant gene 1 MDR-1 Gene array analysis and extreme drug resistant assays are also performed
After completion of study treatment patients are followed every 3 months for 2 years
Primary
Determine whether at least 50 of patients with advanced ovarian epithelial fallopian tube or primary peritoneal cavity cancer are able to achieve optimal cytoreduction to 1 centimeter of remaining disease after neoadjuvant chemotherapy comprising paclitaxel and carboplatin
Secondary
Determine the frequency and severity of toxicity associated with this regimen in patients who are high-risk surgical candidates or in patients unlikely to achieve optimal surgical cytoreduction
Determine if extreme drug resistance assay profiles change after neoadjuvant chemotherapy
Determine how thrombospondin-1 TSP-1 tumor protein 53 p53 and tumor vessel density change after administration of neoadjuvant chemotherapy
Assess the quality of life of patients receiving neoadjuvant chemotherapy
Obtain estimates of tumor response after administration of neoadjuvant chemotherapy
Determine whether serum cancer antigen 125 CA-125 at the time of cytoreduction is associated with the ability to optimally reduce the patients
OUTLINE This is an open-label study
Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Within 4-6 weeks after the fourth course of chemotherapy patients undergo interval cytoreductive surgery
Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and are re-evaluated for surgery after the sixth course of chemotherapy
Within 4 weeks after surgery patients receive 2 additional courses of chemotherapy
Quality of life is assessed periodically
Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning chemotherapy and during interval cytoreduction Tissue is examined by immunohistochemistry staining for p53 TSP-1 microvessel density CD31 angiogenesis membrane protein BCL-2 and multidrug resistant gene 1 MDR-1 Gene array analysis and extreme drug resistant assays are also performed
After completion of study treatment patients are followed every 3 months for 2 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 |
|---|---|---|---|
| UMN- WCC-40 | OTHER | Womens Cancer Center University of Minnesota | None |
| UMN-0409M64006 | OTHER | None | None |