Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00520000
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with advanced or metastatic solid tumors.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose (MTD) of paclitaxel albumin-stabilized nanoparticle formulation given once weekly for 3 weeks when administered with carboplatin given once every 4 weeks.
* Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given once every 3 weeks when administered with carboplatin given once every 3 weeks.
* Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given in weeks 1 and 2 when administered with carboplatin given once every 3 weeks.
* Evaluate sequence-dependent effects on toxicity and pharmacokinetics in the combination of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin.
Secondary
* Explore the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation given once weekly or once every 3 weeks.
OUTLINE: Patients are assigned to 1 of 3 treatment arms.
* Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients in arms I and II undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed at 30 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weekly Arm Abraxane Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle Every 3 week Arm Carboplatin Carboplatin day 1, abraxane day 1, every 21 day cycle Every 3 week Arm Abraxane Carboplatin day 1, abraxane day 1, every 21 day cycle Arm C Abraxane Carboplatin day 1, abraxane day 1, 8 every 21 day cycle Weekly Arm Carboplatin Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle Arm C Carboplatin Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of Abraxane 28 days To determine the maximum tolerated dose (MTD) of Abraxane weekly days 1, 8, 15 with a carboplatin dose of AUC=6 given on day 1 of a 28 day cycle
Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin 21 days To determine the MTD of Abraxane given every 3 weeks with carboplatin given on day 1 of a 21 day cycle
Sequence-dependent toxicity 28 days To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
- Secondary Outcome Measures
Name Time Method