Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003847
Status:
TERMINATED
Last Update Posted:
2013-09-05
First Post:
1999-11-01
Brief Title:
VX-710 Doxorubicin and Vincristine for the Treatment of Patients With Recurrent Small Cell Lung Cancer
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Vertex Pharmaceuticals Incorporated
Study Overview
Official Title:
A Phase II Study of the Safety Efficacy and Pharmacokinetics of VX-710 in Combination With Doxorubicin and Vincristine in Patients With Small Cell Lung Cancer SCLC
Status:
TERMINATED
Status Verified Date:
2013-09
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 tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy for the treatment of patients who have recurrent small cell lung cancer following treatment
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy for the treatment of patients who have recurrent small cell lung cancer following treatment
Detailed Description:
OBJECTIVES I Established the safety of VX-710 in combination with doxorubicin and vincristine for the treatment of patients with recurrent small cell lung cancer II Characterized the plasma pharmacokinetics of this regimen in patients III Established the ability of this regimen to improve the response rate to chemotherapy in patients who relapsed on front-line therapy IV Evaluated the multidrug resistance profile of these patients following this treatment regimen
OUTLINE This was a multicenter study Stage I Patients received VX-710 IV over 72 hours followed by doxorubicin IV and vincristine IV four hours after initial VX-710 Vincristine was administered at half dose in the first 3-6 patients If no more than 1 of 6 patients experienced a dose limiting toxicity in the half dose cohort 3 additional patients received full dose vincristine The maximum tolerated dose was defined as the dose preceding that at which 2 of 6 patients experienced a dose limiting toxicity Stage II Patients received VX-710 IV over 72 hours followed by doxorubicin IV and full dose vincristine IV four hours after initial VX-710 Treatment continued for up to 6 courses every 3 weeks in the absence of disease progression or unacceptable toxicity Patients were followed every 3 months for up to 1 year
PROJECTED ACCRUAL A minimum of 35 and a maximum of 92 patients was to be accrued for this study
OUTLINE This was a multicenter study Stage I Patients received VX-710 IV over 72 hours followed by doxorubicin IV and vincristine IV four hours after initial VX-710 Vincristine was administered at half dose in the first 3-6 patients If no more than 1 of 6 patients experienced a dose limiting toxicity in the half dose cohort 3 additional patients received full dose vincristine The maximum tolerated dose was defined as the dose preceding that at which 2 of 6 patients experienced a dose limiting toxicity Stage II Patients received VX-710 IV over 72 hours followed by doxorubicin IV and full dose vincristine IV four hours after initial VX-710 Treatment continued for up to 6 courses every 3 weeks in the absence of disease progression or unacceptable toxicity Patients were followed every 3 months for up to 1 year
PROJECTED ACCRUAL A minimum of 35 and a maximum of 92 patients was to 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-V99-1537 | None | None | None |
| VX-98-710-006 | None | None | None |
| DUMC-1450-98-9 | None | None | None |