Clinical trial NCT00454324
Conditions: Small Cell Lung Cancer
Keywords: Lung cancer Small cell lung cancer Abraxane Paclitaxel Carboplatin Phase II Randomized Lineberger LCCC
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2006-04-01; Completion date: 2014-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

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 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.

Arms: arm 1: Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles arm 2: Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Interventions: intervention 1: Carboplatin intervention 2: Abraxane
Intervention descriptions: intervention 1: 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 intervention 2: 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)

Protocol documents: