Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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.
Interventions
DRUGCarboplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
DRUGAbraxane
75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed solid tumor * Advanced or metastatic disease * Measurable or evaluable disease * Must meet 1 of the following criteria: * Failed a standard therapy * Not a candidate for standard therapy * Have a disease for which there is no defined standard therapy
Exclusion criteria
* Symptomatic brain metastases PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Life expectancy ≥ 8 weeks * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Total bilirubin normal * Serum creatinine normal OR creatinine clearance ≥ 60 mL/min * AST and ALT ≤ 2.5 x upper limit of normal * Negative pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed