Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005972
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of GemcitabineIrinotecan as Second Line Therapy for Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 in treating patients who have recurrent or refractory small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the overall complete and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan II Determine the overall and failure free survival of these patients when treated with this regimen III Determine the duration of response of these patients after this treatment IV Evaluate the toxicity associated with the administration of this treatment in this patient population
OUTLINE Patients are stratified according to prior response duration progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year then every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 78 patients will be accrued for this study over 12-18 months
OUTLINE Patients are stratified according to prior response duration progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year then every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 78 patients will be accrued for this study over 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 |
|---|---|---|---|
| CDR0000067959 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-39902 | None | None | None |