Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006010
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2000-07-05
Brief Title:
Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer
PURPOSE Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer
Detailed Description:
OBJECTIVES
Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel
Determine tumor response and time to progression in this patient population treated with this regimen
Determine the toxicity of this regimen in these patients
Assess the pharmacokinetics of docetaxel in patients treated with this regimen
OUTLINE Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy Patients with stable disease or partial response continue therapy until disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel
Determine tumor response and time to progression in this patient population treated with this regimen
Determine the toxicity of this regimen in these patients
Assess the pharmacokinetics of docetaxel in patients treated with this regimen
OUTLINE Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy Patients with stable disease or partial response continue therapy until disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 4 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 |
|---|---|---|---|
| CDR0000068019 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02349 | REGISTRY | None | None |