A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 47
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of Abraxane
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Weekly Arm
Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
Intervention: Carboplatin (Drug)
Weekly Arm
Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
Intervention: Abraxane (Drug)
Every 3 week Arm
Carboplatin day 1, abraxane day 1, every 21 day cycle
Intervention: Carboplatin (Drug)
Every 3 week Arm
Carboplatin day 1, abraxane day 1, every 21 day cycle
Intervention: Abraxane (Drug)
Arm C
Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
Intervention: Carboplatin (Drug)
Arm C
Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
Intervention: Abraxane (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of Abraxane
Time Frame: 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
Time Frame: 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
Time Frame: 28 days
To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
Secondary Outcomes
No secondary outcomes reported