Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003943
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial of High Dose Paclitaxel Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic cancer
Detailed Description:
OBJECTIVES I Evaluate one year progression free survival complete response rate and overall survival in patients with metastatic small cell cancer treated with high dose paclitaxel carboplatin and topotecan with peripheral blood stem cell support II Assess the safety of this treatment regimen in this patient population
OUTLINE Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1 and filgrastim G-CSF subcutaneously beginning on day 3 and continuing through the day prior to the last collection day Peripheral blood stem cells PBSC are collected over 3-5 days Beginning approximately 21 days following mobilization patients receive paclitaxel IV over 24 hours on day 1 immediately followed by carboplatin IV over 2 hours and topotecan IV over 24 hours on day 2 then G-CSF subcutaneously beginning on day 4 and continuing until blood counts recover PBSC are reinfused on day 5 Patients receive 13 of PBSC with each course Treatment repeats every 4 weeks for 3 courses in the absence of unacceptable toxicity Patients are followed at week 8 after treatment then every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
OUTLINE Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1 and filgrastim G-CSF subcutaneously beginning on day 3 and continuing through the day prior to the last collection day Peripheral blood stem cells PBSC are collected over 3-5 days Beginning approximately 21 days following mobilization patients receive paclitaxel IV over 24 hours on day 1 immediately followed by carboplatin IV over 2 hours and topotecan IV over 24 hours on day 2 then G-CSF subcutaneously beginning on day 4 and continuing until blood counts recover PBSC are reinfused on day 5 Patients receive 13 of PBSC with each course Treatment repeats every 4 weeks for 3 courses in the absence of unacceptable toxicity Patients are followed at week 8 after treatment then every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 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 |
|---|---|---|---|
| NCI-G99-1535 | OTHER_GRANT | National Cancer Institute | None |
| FCCC-98039 | OTHER | None | None |