Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093496
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2004-10-06
Brief Title:
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin 17-AAG In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-10
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 gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer Drugs used in chemotherapy such as gemcitabine hydrochloride and tanespimycin work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate time to progression and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin
II Determine the toxicity of this regimen in these patients III Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response time to progression and survival of these patients
OUTLINE This is a multicenter study Patients are stratified according to gemcitabine hydrochloride therapy gemcitabine hydrochloride-naiveno prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistantprior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment Patients receive tanespimycin intravenously IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years
I Determine the response rate time to progression and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin
II Determine the toxicity of this regimen in these patients III Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response time to progression and survival of these patients
OUTLINE This is a multicenter study Patients are stratified according to gemcitabine hydrochloride therapy gemcitabine hydrochloride-naiveno prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistantprior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment Patients receive tanespimycin intravenously IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until disease progression and then every 6 months for up to 5 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 |
|---|---|---|---|
| NCI-2009-00052 | REGISTRY | None | None |
| CDR0000388036 | None | None | None |
| NCI-6307 | None | None | None |
| MAYO-MC0362 | None | None | None |
| MC0362 | OTHER | None | None |
| 6307 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| N01CM62205 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62205 |