Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077103
Status:
TERMINATED
Last Update Posted:
2010-06-11
First Post:
2004-02-10
Brief Title:
Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Combined Modality Combretastatin A-4 Phosphate CA4P-Based Therapy for Patients With Newly Diagnosed Anaplastic Thyroid Cancer Induction Chemotherapy With DoxorubicinCisplatin Combined Modality Therapy With CA4P and Radiation Followed by 2 Cycles of CA4P Consolidation
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
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 such as doxorubicin and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combretastatin A4 phosphate may stop the growth of cancer by stopping blood flow to the tumor Combining doxorubicin and cisplatin with radiation therapy and combretastatin A4 phosphate may kill more tumor cells
PURPOSE This phase II trial is studying how well giving induction chemotherapy using doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate works in treating patients with newly diagnosed regionally advanced anaplastic thyroid cancer
PURPOSE This phase II trial is studying how well giving induction chemotherapy using doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate works in treating patients with newly diagnosed regionally advanced anaplastic thyroid cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with newly diagnosed regionally advanced anaplastic thyroid cancer treated with induction chemotherapy comprising doxorubicin and cisplatin followed by combretastatin A4 phosphate CA4P and radiotherapy
Determine whether this regimen alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of these patients from 10 to 20 months
Secondary
Determine a tolerable dose of CA4P when administered with radiotherapy in these patients Phase I portion of the study closed as of 5604 patients now receive a fixed dose of CA4P
Determine the safety profile of this regimen in these patients
Determine clinical predictors of response eg pretreatment tumor microvessel density and immature vessel staining changes in sICAM-1 levels and tumor blood flow and pharmacokinetic parameters in patients treated with this regimen
Correlate the diminution in blood flow with tumor pain and response in patients treated with this regimen
OUTLINE This is a multicenter study of combretastatin A4 phosphate CA4P Phase I portion of the study closed as of 5604 patients now receive a fixed dose of CA4P
Induction phase Patients receive doxorubicin IV over 5-10 minutes and cisplatin IV over 30-60 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously SC on days 3-21 or pegfilgrastim SC on day 2
Combined modality phase Beginning on day 22 patients undergo radiotherapy twice daily 5 days a week for 3-4 weeks Patients also receive CA4P IV over 10 minutes weekly on the fifth day of radiotherapy
Cohorts of 6 patients receive 1 of 2 escalating doses of CA4P to determine a tolerable dose The tolerable dose is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity Phase I portion of the study closed as of 5604 patients now receive a fixed dose of CA4P
Consolidation phase Beginning 4-6 weeks after the completion of the combined modality phase patients receive CA4P IV over 10 minutes on days 1 8 and 15 Treatment repeats every 28 days for 2 courses
Treatment in all phases continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 2 years from study entry
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study within 18 months
Primary
Determine the objective response rate in patients with newly diagnosed regionally advanced anaplastic thyroid cancer treated with induction chemotherapy comprising doxorubicin and cisplatin followed by combretastatin A4 phosphate CA4P and radiotherapy
Determine whether this regimen alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of these patients from 10 to 20 months
Secondary
Determine a tolerable dose of CA4P when administered with radiotherapy in these patients Phase I portion of the study closed as of 5604 patients now receive a fixed dose of CA4P
Determine the safety profile of this regimen in these patients
Determine clinical predictors of response eg pretreatment tumor microvessel density and immature vessel staining changes in sICAM-1 levels and tumor blood flow and pharmacokinetic parameters in patients treated with this regimen
Correlate the diminution in blood flow with tumor pain and response in patients treated with this regimen
OUTLINE This is a multicenter study of combretastatin A4 phosphate CA4P Phase I portion of the study closed as of 5604 patients now receive a fixed dose of CA4P
Induction phase Patients receive doxorubicin IV over 5-10 minutes and cisplatin IV over 30-60 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously SC on days 3-21 or pegfilgrastim SC on day 2
Combined modality phase Beginning on day 22 patients undergo radiotherapy twice daily 5 days a week for 3-4 weeks Patients also receive CA4P IV over 10 minutes weekly on the fifth day of radiotherapy
Cohorts of 6 patients receive 1 of 2 escalating doses of CA4P to determine a tolerable dose The tolerable dose is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity Phase I portion of the study closed as of 5604 patients now receive a fixed dose of CA4P
Consolidation phase Beginning 4-6 weeks after the completion of the combined modality phase patients receive CA4P IV over 10 minutes on days 1 8 and 15 Treatment repeats every 28 days for 2 courses
Treatment in all phases continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 2 years from study entry
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| OXIGENE-CWRU-3302 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CASE-CWRU-3302 | OTHER | None | None |
| CWRU-040337 | None | None | None |