Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002903
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer
Detailed Description:
OBJECTIVES I Determine whether partial or complete responses can be achieved with docetaxel TXT in patients with recurrent or refractory disseminated germ cell cancer previously treated with standard-dose chemotherapy II Assess the probability of actual response warranting further evaluation of the therapeutic effectiveness of TXT in the case that partial or complete tumor responses are achieved in this patient population III Characterize further the toxic effects of TXT in these patients
OUTLINE Patients receive intravenous docetaxel over 1 hour every 3 weeks until disease progression unacceptable toxicity or at least 3 courses beyond documentation of complete response Patients may receive concurrent radiotherapy provided not all indicator lesions are included in irradiated field Resection of residual mature teratoma is allowed no sooner than 8 weeks after therapy provided tumor markers are normalized for at least 4 weeks
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
OUTLINE Patients receive intravenous docetaxel over 1 hour every 3 weeks until disease progression unacceptable toxicity or at least 3 courses beyond documentation of complete response Patients may receive concurrent radiotherapy provided not all indicator lesions are included in irradiated field Resection of residual mature teratoma is allowed no sooner than 8 weeks after therapy provided tumor markers are normalized for at least 4 weeks
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-16945T | None | None | None |