Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026091
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2001-11-09
Brief Title:
Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Fenretinide NSC 374551 in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer Drugs used in chemotherapy such as fenretinide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the efficacy of fenretinide 4-HPR in patients with recurrent ovarian cancer or primary peritoneal carcinoma
II To assess the toxicity of this agent in this patient population III To evaluate molecular changes in normal and tumor cells induced by 4-HPR by studying a the analysis of ceramide and glucosyleceramide levels before and after therapy b intracellular levels of 4-HPR and 4-MPR and c determinants of apoptosis p53 p21 bcl-2 bax and terminal deoxynucleotidyl transferase TdT assay in baseline tumor specimens serial serum and tumor biopsy specimens where available and surrogate in-vitro studies
IV To evaluate the pharmacokinetics of fenretinide V To further investigate the antiangiogenesis effects of fenretinide in in-vitro assays using ovarian cancer cell lines and in vascular growth factor VEGF TGFb plasma levels in patients
OUTLINE
Patients receive oral fenretinide twice daily on days 1-7 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
I To evaluate the efficacy of fenretinide 4-HPR in patients with recurrent ovarian cancer or primary peritoneal carcinoma
II To assess the toxicity of this agent in this patient population III To evaluate molecular changes in normal and tumor cells induced by 4-HPR by studying a the analysis of ceramide and glucosyleceramide levels before and after therapy b intracellular levels of 4-HPR and 4-MPR and c determinants of apoptosis p53 p21 bcl-2 bax and terminal deoxynucleotidyl transferase TdT assay in baseline tumor specimens serial serum and tumor biopsy specimens where available and surrogate in-vitro studies
IV To evaluate the pharmacokinetics of fenretinide V To further investigate the antiangiogenesis effects of fenretinide in in-vitro assays using ovarian cancer cell lines and in vascular growth factor VEGF TGFb plasma levels in patients
OUTLINE
Patients receive oral fenretinide twice daily on days 1-7 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000068985 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17101 |
| PHII-25 | None | None | None |
| N01CM17101 | NIH | None | None |