Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103389
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2005-02-07
Brief Title:
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Cellxpert Biotechnology Corp
Organization:
Cellxpert Biotechnology Corp
Study Overview
Official Title:
A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-06
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:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor It may also help docetaxel work better by making tumor cells more sensitive to the drug Giving docetaxel together with PI-88 may kill more tumor cells It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer
PURPOSE This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer
Secondary
Determine the efficacy markers of docetaxel and PI-88 in these patients
Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy
Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on days 1 8 and 15
Arm II Patients receive docetaxel as in arm I Patients also receive PI-88 subcutaneously once daily on days 1-4 8-11 and 15-18
In both arms treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy
PROJECTED ACCRUAL Approximately 100 patients will be accrued for this study
Primary
Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer
Secondary
Determine the efficacy markers of docetaxel and PI-88 in these patients
Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy
Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on days 1 8 and 15
Arm II Patients receive docetaxel as in arm I Patients also receive PI-88 subcutaneously once daily on days 1-4 8-11 and 15-18
In both arms treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy
PROJECTED ACCRUAL Approximately 100 patients will 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 |
|---|---|---|---|
| AUS-RNSH-0309-183M | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000409568 | REGISTRY | None | None |