Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005997
Status:
TERMINATED
Last Update Posted:
2010-06-11
First Post:
2000-07-05
Brief Title:
Rebeccamycin Analogue in Treating Patients With Advanced Liver andor Biliary Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual for Cohort II
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 rebeccamycin analogue in treating patients who have advanced liver andor biliary cancer
PURPOSE Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver andor biliary cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue
Assess the toxicity associated with this drug in this patient population
Evaluate the survival of this patient population treated with this drug
Determine the pharmacokinetics of this drug in this patient population
OUTLINE This is a partial dose-escalation study
Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction Cohort I closed to accrual as of 11103
Cohort I closed to accrual as of 11103 Patients receive a fixed dose of rebeccamycin analogue
Cohort II Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue 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
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-37 months
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue
Assess the toxicity associated with this drug in this patient population
Evaluate the survival of this patient population treated with this drug
Determine the pharmacokinetics of this drug in this patient population
OUTLINE This is a partial dose-escalation study
Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction Cohort I closed to accrual as of 11103
Cohort I closed to accrual as of 11103 Patients receive a fixed dose of rebeccamycin analogue
Cohort II Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue 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
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-37 months
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-96 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| U01CA063200 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-2299 | OTHER | None | None |