Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-01 @ 9:44 AM
Study NCT ID:
NCT00118235
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2005-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Cisplatin, Irinotecan and Bevacizumab (NSC# 704865) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This phase II trial is studying how well giving cisplatin and irinotecan together with bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan together with bevacizumab may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the percentage of patients with extensive stage small cell lung cancer treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months.
SECONDARY OBJECTIVES:
I. To assess the response rate of patients treated with cisplatin, irinotecan and bevacizumab.
II. To evaluate the toxicity and tolerability of the combination of cisplatin, irinotecan and bevacizumab.
III. To determine the association between VEGF/KDR complex expression and VEGF plasma levels and tumor response.
OUTLINE:
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
I. To determine the percentage of patients with extensive stage small cell lung cancer treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months.
SECONDARY OBJECTIVES:
I. To assess the response rate of patients treated with cisplatin, irinotecan and bevacizumab.
II. To evaluate the toxicity and tolerability of the combination of cisplatin, irinotecan and bevacizumab.
III. To determine the association between VEGF/KDR complex expression and VEGF plasma levels and tumor response.
OUTLINE:
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02815 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000433341 | None | None | View | |
| CALGB-30306 | OTHER | Cancer and Leukemia Group B | View | |
| CALGB-30306 | OTHER | CTEP | View | |
| U10CA031946 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA014236 | NIH | None | https://reporter.nih.gov/quic… | View |