Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025480
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2001-10-11
Brief Title:
Tipifarnib Plus Radiation Therapy After Combination Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Phase I Trial of Farnesyltransferase Inhibitor R115777 NSC 702818 and Radiotherapy in Patients With Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by making tumor cells more sensitive to radiation therapy Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing and may also make tumor cells more sensitive to radiation therapy
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given together with radiation therapy after combination chemotherapy in treating patients with stage III non-small cell lung cancer
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given together with radiation therapy after combination chemotherapy in treating patients with stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of tipifarnib given concurrently with radiotherapy after induction chemotherapy comprising paclitaxel and carboplatin and followed by maintenance therapy with tipifarnib in patients with stage IIIA or IIIB non-small cell lung cancer
Determine the tumor response at 3 months in patients treated with this regimen
OUTLINE This is multicenter dose-escalation study of tipifarnib
Patients receive induction chemotherapy comprising carboplatin IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for 2 courses
Beginning 4-6 weeks after the completion of induction chemotherapy patients receive oral tipifarnib twice daily for 7 weeks Patients undergo radiotherapy once daily 5 days a week for 7 weeks beginning 3 days after the start of tipifarnib After completion of radiotherapy patients receive oral tipifarnib twice daily for 4 days and then once daily for 4 days
Cohorts of 3-6 patients receive escalating doses of tipifarnib while receiving radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Beginning 4-6 weeks after the completion of radiotherapy and tipifarnib patients receive maintenance therapy comprising oral tipifarnib twice daily on days 1-21 Maintenance therapy repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 6 and 12 months
PROJECTED ACCRUAL Approximately 9-12 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose and dose-limiting toxicity of tipifarnib given concurrently with radiotherapy after induction chemotherapy comprising paclitaxel and carboplatin and followed by maintenance therapy with tipifarnib in patients with stage IIIA or IIIB non-small cell lung cancer
Determine the tumor response at 3 months in patients treated with this regimen
OUTLINE This is multicenter dose-escalation study of tipifarnib
Patients receive induction chemotherapy comprising carboplatin IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for 2 courses
Beginning 4-6 weeks after the completion of induction chemotherapy patients receive oral tipifarnib twice daily for 7 weeks Patients undergo radiotherapy once daily 5 days a week for 7 weeks beginning 3 days after the start of tipifarnib After completion of radiotherapy patients receive oral tipifarnib twice daily for 4 days and then once daily for 4 days
Cohorts of 3-6 patients receive escalating doses of tipifarnib while receiving radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Beginning 4-6 weeks after the completion of radiotherapy and tipifarnib patients receive maintenance therapy comprising oral tipifarnib twice daily on days 1-21 Maintenance therapy repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 6 and 12 months
PROJECTED ACCRUAL Approximately 9-12 patients will be accrued for this study within 1 year
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-5150 | None | None | None |
| UPCC-NCI-5150 | None | None | None |