Viewing Study NCT00066456



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00066456
Status: COMPLETED
Last Update Posted: 2016-02-11
First Post: 2003-08-06

Brief Title: Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian Peritoneal or Fallopian Tube Cancer
Sponsor: Gynecologic Oncology Group
Organization: GOG Foundation

Study Overview

Official Title: A Phase I Study Using Low Dose Abdominal Radiotherapy as A Docetaxel Chemosensitizer for Recurrent Persistent Or Advanced Ovarian Peritoneal Or Fallopian Tube Cancer
Status: COMPLETED
Status Verified Date: 2016-02
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 I trial to study the effectiveness of low-dose radiation therapy to the abdomen combined with docetaxel in treating patients who have recurrent or persistent advanced ovarian peritoneal or fallopian tube cancer Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy may kill more tumor cells
Detailed Description: OBJECTIVES

I Determine the maximum tolerated dose of docetaxel in combination with low-dose abdominal radiotherapy in patients with recurrent or persistent advanced ovarian peritoneal or fallopian tube cancer

II Determine the safety and toxicity of this regimen in these patients

OUTLINE This is a multicenter dose-escalation study of docetaxel

Patients receive docetaxel IV over 30 minutes once daily on days 1 8 15 22 29 and 35 Within 3 hours after beginning docetaxel patients also receive low-dose abdominal radiotherapy twice daily at least 4 hours apart on days 1 2 8 9 15 16 22 24 29 30 35 and 36 Treatment continues in the absence of unacceptable toxicity

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity

Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter

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
U10CA027469 NIH CTEP httpsreporternihgovquickSearchU10CA027469
NCI-2009-00618 REGISTRY None None
CDR0000316238 None None None
GOG-9915 None None None
GOG-9915 OTHER None None
GOG-9915 OTHER None None