Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016172
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-05-06
Brief Title:
ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of ZD0473 and Doxil in Patients With Advanced Refractory Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining ZD0473 and doxorubicin in treating patients who have advanced solid tumors or lymphoma
PURPOSE Phase I trial to study the effectiveness of combining ZD0473 and doxorubicin in treating patients who have advanced solid tumors or lymphoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of ZD0473 and doxorubicin HCl liposome in patients with advanced or metastatic solid tumors or lymphoma II Determine the qualitative and quantitative toxic effects of this regimen in this patient population III Determine the pharmacokinetics of these drugs in this patient population IV Determine the antitumor activity of this regimen in this patient population
OUTLINE This is a dose-escalation study Patients receive doxorubicin HCl liposome IV over 60 minutes followed by ZD0473 IV over 60 minutes on day 1 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients with partial response PR or complete response CR may continue treatment until disease progression or until 2 courses after maximum response Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome and ZD0473 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity Patients are followed at 4 weeks and 3 months Patients with PR or CR ongoing continue follow-up every 3 months until relapse
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive doxorubicin HCl liposome IV over 60 minutes followed by ZD0473 IV over 60 minutes on day 1 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients with partial response PR or complete response CR may continue treatment until disease progression or until 2 courses after maximum response Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome and ZD0473 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity Patients are followed at 4 weeks and 3 months Patients with PR or CR ongoing continue follow-up every 3 months until relapse
PROJECTED ACCRUAL Approximately 24 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 |
|---|---|---|---|
| NCI-G01-1942 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068603 | REGISTRY | None | None |