Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047307
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-10-03
Brief Title:
Flavopiridol Plus Radiation Therapy Followed By Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of Alvocidib Flavopiridol in Combination With Radiation in Locally Advanced Non-Operable Pancreatic and Extrahepatic Bile Duct Cancers
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:
Drugs used in chemotherapy work 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 Flavopiridol may make the tumor cells more sensitive to radiation therapy Phase I trial to study the effectiveness of combining flavopiridol with radiation therapy followed by gemcitabine hydrochloride in treating patients who have locally advanced unresectable pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of flavopiridol in combination with radiotherapy followed by gemcitabine in patients with locally advanced unresectable pancreatic cancer
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of flavopiridol in these patients II Determine preliminarily the therapeutic activity of this regimen in these patients
OUTLINE This is a dose-escalation study of flavopiridol
Patients receive flavopiridol IV over 1 hour twice weekly on days 1 and 4 or days 2 and 5 for 6 weeks Concurrently patients undergo radiotherapy once daily 5 days a week for 55 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Four weeks after the completion of radiotherapy patients are re-evaluated Beginning within 4-7 weeks after the completion of chemotherapy and radiotherapy patients receive gemcitabine hydrochloride alone or in combination with another cytotoxic agent or gemcitabine hydrochloride combined with a targeted drug eg erlotinib or bevacizumab at the discretion of the oncologist NOTE Patients whose imaging studies suggest potential curative resection are referred for a surgical evaluation before initiating gemcitabine hydrochloride therapy Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated at the recommended phase II dose
Patients are followed at 4 weeks and then every 8 weeks thereafter
PROJECTED ACCRUAL Approximately 3-46 patients will be accrued for this study within 2 years
I Determine the maximum tolerated dose of flavopiridol in combination with radiotherapy followed by gemcitabine in patients with locally advanced unresectable pancreatic cancer
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of flavopiridol in these patients II Determine preliminarily the therapeutic activity of this regimen in these patients
OUTLINE This is a dose-escalation study of flavopiridol
Patients receive flavopiridol IV over 1 hour twice weekly on days 1 and 4 or days 2 and 5 for 6 weeks Concurrently patients undergo radiotherapy once daily 5 days a week for 55 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Four weeks after the completion of radiotherapy patients are re-evaluated Beginning within 4-7 weeks after the completion of chemotherapy and radiotherapy patients receive gemcitabine hydrochloride alone or in combination with another cytotoxic agent or gemcitabine hydrochloride combined with a targeted drug eg erlotinib or bevacizumab at the discretion of the oncologist NOTE Patients whose imaging studies suggest potential curative resection are referred for a surgical evaluation before initiating gemcitabine hydrochloride therapy Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated at the recommended phase II dose
Patients are followed at 4 weeks and then every 8 weeks thereafter
PROJECTED ACCRUAL Approximately 3-46 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| 02-057 | None | None | None |
| NCI-5764 | None | None | None |
| MSKCC-02057 | None | None | None |
| CDR0000257662 | None | None | None |
| U01CA069856 | NIH | None | None |
| R01CA067819 | NIH | None | httpsreporternihgovquickSearchR01CA067819 |