Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454324
Status:
TERMINATED
Last Update Posted:
2017-07-11
First Post:
2007-03-28
Brief Title:
Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NRR
Brief Summary:
This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung cancer to examine overall response rate time to progressive disease survival time and assessment of toxicity profile for Carboplatin and Abraxane
Detailed Description:
Patients are being asked to be in this study because they have extensive disease small cell lung cancer All eligible participants who agree to be in the study will receive both abraxane and carboplatin The researchers want to evaluate the activity and safety of the combination of abraxane and carboplatin and if this combination can help people with extensive disease small cell lung cancer
Carboplatin is a chemotherapy drug that has been approved by the Food and Drug Administration FDA to treat ovarian cancer It is in a class of drugs known as platinum-containing compounds It slows or stops the growth of cancer cells in your body Carboplatin is not approved by the FDA for use in the treatment of small-cell lung cancer either alone or combined with other anti-cancer drugs However carboplatin given with paclitaxel is a standard or active treatment in patients with small cell lung cancer non-small cell lung cancer breast cancer and ovarian cancer Abraxane is a chemotherapy drug that was approved by the FDA to treat metastatic breast cancer after other chemotherapy has already been tried Abraxane is a new preparation of the active ingredient in the chemotherapy drug paclitaxel In a study done in breast cancer patients Abraxane was compared to paclitaxel Abraxane has been shown to be more effective than paclitaxel in tumor response and tumor progression in addition to having fewer side effects than paclitaxel Abraxane was shown to cause less damage to a persons white blood cells the cells that fight infection and cause fewer allergic reactions however more patients developed numbness of their hands and feet
Carboplatin and Abraxane are intravenous IV medications Patients will begin treatment with 2 cycles 1 cycle 21 days of abraxane and carboplatin Then there will be a disease assessment at cycles 2 and 4 Patients with stable disease partial response or complete response will get additional cycles Patients with progressive disease no will be taken off the study treatment A maximum of 6 cycles will be given
Carboplatin is a chemotherapy drug that has been approved by the Food and Drug Administration FDA to treat ovarian cancer It is in a class of drugs known as platinum-containing compounds It slows or stops the growth of cancer cells in your body Carboplatin is not approved by the FDA for use in the treatment of small-cell lung cancer either alone or combined with other anti-cancer drugs However carboplatin given with paclitaxel is a standard or active treatment in patients with small cell lung cancer non-small cell lung cancer breast cancer and ovarian cancer Abraxane is a chemotherapy drug that was approved by the FDA to treat metastatic breast cancer after other chemotherapy has already been tried Abraxane is a new preparation of the active ingredient in the chemotherapy drug paclitaxel In a study done in breast cancer patients Abraxane was compared to paclitaxel Abraxane has been shown to be more effective than paclitaxel in tumor response and tumor progression in addition to having fewer side effects than paclitaxel Abraxane was shown to cause less damage to a persons white blood cells the cells that fight infection and cause fewer allergic reactions however more patients developed numbness of their hands and feet
Carboplatin and Abraxane are intravenous IV medications Patients will begin treatment with 2 cycles 1 cycle 21 days of abraxane and carboplatin Then there will be a disease assessment at cycles 2 and 4 Patients with stable disease partial response or complete response will get additional cycles Patients with progressive disease no will be taken off the study treatment A maximum of 6 cycles will be given
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 |
|---|---|---|---|
| CDR0000542753 | OTHER | PDQ number | None |