NCT00454324

Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 person's 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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin will be given at a dose of target area under the concentration versus time curve in mg/mL•min (AUC)=6, on Day 1 of a 21 Day Cycle
DRUG	Abraxane	Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A) Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-07-01
• Completion: 2014-12-01
• First posted: 2007-03-30
• Last updated: 2017-07-11
• Results posted: 2017-06-12

Locations

1 site across 1 country: United States