Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352300
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2006-07-13
Brief Title:
Carboplatin Paclitaxel and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial Fallopian Tube Primary Peritoneal or Carcinosarcoma Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Trial of Dose Dense Biweekly Carboplatin Combined With Paclitaxel and Pegfilgrastim Neulasta A Feasibility Study in Patients With Untreated Stage III and IV Ovarian Tubal or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2014-12
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:
None
Brief Summary:
This phase I trial is studying the side effects of giving carboplatin and paclitaxel together with pegfilgrastim in treating patients with stage III or stage IV ovarian epithelial fallopian tube primary peritoneal or carcinosarcoma cancer 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 by stopping them from dividing Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving carboplatin and paclitaxel together with pegfilgrastim after surgery may kill any tumor cells that remain after surgery
Detailed Description:
PRIMARY OBJECTIVES
I Establish the feasibility of adjuvant dose-dense carboplatin and paclitaxel followed by pegfilgrastim in terms of absence of grade 3 or 4 nonhematologic toxicities without major dose delays or additional hematological support eg red blood cell or platelet transfusions or admission for febrile neutropenia in patients with stage III-IV ovarian epithelial fallopian tube primary peritoneal cancer or carcinosarcoma cancer
SECONDARY OBJECTIVES
I Estimate the percentage of patients who develop grade 2 peripheral neurotoxicity from this regimen
II Estimate the clinical response rate in patients with measurable disease treated with this regimen
III Assess the toxicity of this regimen
OUTLINE This is a multicenter study
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1 Patients also receive pegfilgrastim subcutaneously on day 2 Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year
I Establish the feasibility of adjuvant dose-dense carboplatin and paclitaxel followed by pegfilgrastim in terms of absence of grade 3 or 4 nonhematologic toxicities without major dose delays or additional hematological support eg red blood cell or platelet transfusions or admission for febrile neutropenia in patients with stage III-IV ovarian epithelial fallopian tube primary peritoneal cancer or carcinosarcoma cancer
SECONDARY OBJECTIVES
I Estimate the percentage of patients who develop grade 2 peripheral neurotoxicity from this regimen
II Estimate the clinical response rate in patients with measurable disease treated with this regimen
III Assess the toxicity of this regimen
OUTLINE This is a multicenter study
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1 Patients also receive pegfilgrastim subcutaneously on day 2 Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| NCI-2009-00622 | REGISTRY | None | None |
| CDR0000486412 | None | None | None |
| GOG-9919 | None | None | None |
| GOG-9919 | OTHER | None | None |
| GOG-9919 | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |