Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005032
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-04-06
Brief Title:
Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase III Study of G3139 a BCL-2 Antisense Oligonucleotide Combined With Paclitaxel for the Treatment of Recurrent Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 Bcl-2 antisense oligodeoxynucleotide G3139 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug
PURPOSE Phase III trial to study the effectiveness of bcl-2 antisense oligodeoxynucleotide G3139 and paclitaxel in treating patients who have recurrent small cell lung cancer
PURPOSE Phase III trial to study the effectiveness of bcl-2 antisense oligodeoxynucleotide G3139 and paclitaxel in treating patients who have recurrent small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the toxicity and feasibility of paclitaxel administration during continuous intravenous bcl-2 antisense oligodeoxynucleotide G3139 in patients with recurrent small cell lung cancer II Evaluate the clinical response of this patient population when treated with this regimen III Evaluate the correlation between bcl-2 expression in these patients and efficacy of this therapy
OUTLINE Patients are stratified according to whether they have received prior taxane therapy yes vs no Patients receive bcl-2 antisense oligodeoxynucleotide G3139 IV continuously on days 1-6 followed by 2 weeks of rest Paclitaxel IV is administered over 3 hours on day 6 of each course Treatment continues for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Intrapatient dose escalation is allowed Patients are followed until death
PROJECTED ACCRUAL A total of 19-33 patients will be accrued for this study within 12-18 months
OUTLINE Patients are stratified according to whether they have received prior taxane therapy yes vs no Patients receive bcl-2 antisense oligodeoxynucleotide G3139 IV continuously on days 1-6 followed by 2 weeks of rest Paclitaxel IV is administered over 3 hours on day 6 of each course Treatment continues for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Intrapatient dose escalation is allowed Patients are followed until death
PROJECTED ACCRUAL A total of 19-33 patients will be accrued for this study within 12-18 months
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-T98-0091 | None | None | None |
| UCCRC-10017 | None | None | None |