Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026104
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2001-11-09
Brief Title:
Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Weekly Gemcitabine Paclitaxel and External Irradiation 504 GY Followed by the Farnesyl Transferase Inhibitor R115777 NSC 702818 for Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Randomized phase II trial to compare the effectiveness of gemcitabine paclitaxel and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer Drugs used in chemotherapy use 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 Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer
Detailed Description:
OBJECTIVES
I Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel gemcitabine and radiotherapy with or without tipifarnib
II Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients
III Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients
IV Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to weight loss in the preceding 6 months more than 10 vs 10 or less and tumor dimension at least 5 cm vs less than 5 cm Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy once daily 5 days a week for 55 weeks beginning on day 1 Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 8 15 22 29 and 36
Arm II Patients receive chemoradiotherapy as in arm I Within 3-8 weeks after completion of chemoradiotherapy patients without disease progression receive oral tipifarnib twice daily for 21 days
Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel gemcitabine and radiotherapy with or without tipifarnib
II Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients
III Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients
IV Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to weight loss in the preceding 6 months more than 10 vs 10 or less and tumor dimension at least 5 cm vs less than 5 cm Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy once daily 5 days a week for 55 weeks beginning on day 1 Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 8 15 22 29 and 36
Arm II Patients receive chemoradiotherapy as in arm I Within 3-8 weeks after completion of chemoradiotherapy patients without disease progression receive oral tipifarnib twice daily for 21 days
Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA021661 | NIH | None | httpsreporternihgovquickSearchU10CA021661 |
| RTOG-PA-0020 | None | None | None |
| CDR0000068986 | None | None | None |