Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Abraxane
* Drug: Abraxane
* Drug: Abraxane


Participation Criteria
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Eligibility Criteria
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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 Exclusion criteria: Pregnant or lactating Prior anaphylactic reaction or severe allergic reaction to paclitaxel and/or docetaxel Active infection that requires treatment with antibiotics for > 4 weeks Uncontrolled congestive heart failure Symptomatic coronary artery disease or heart block Myocardial infarction within the past 3 months Peripheral neuropathy ≥ grade 2 from any cause PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or any other therapy for malignancy within the past 3 weeks No concurrent filgrastim, pegfilgrastim, or sargramostim during the first course of therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly Arm<br>Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle | Drug: Carboplatin<br>* standard dose of area under the curve (AUC) AUC of 6 in all arms<br>* Other names: Paraplatin;Drug: Abraxane<br>* 75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle<br>* Other names: Paclitaxil;|
| Experimental: Every 3 week Arm<br>Carboplatin day 1, abraxane day 1, every 21 day cycle | Drug: Carboplatin<br>* standard dose of area under the curve (AUC) AUC of 6 in all arms<br>* Other names: Paraplatin;Drug: Abraxane<br>* 180mg/m2 - 340mg/m2, repeated every 21 days<br>* Other names: Paclitaxil;|
| Experimental: Arm C<br>Carboplatin day 1, abraxane day 1, 8 every 21 day cycle | Drug: Carboplatin<br>* standard dose of area under the curve (AUC) AUC of 6 in all arms<br>* Other names: Paraplatin;Drug: Abraxane<br>* 100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle<br>* Other names: Paclitaxil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) of Abraxane | 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 | 28 days | 
| Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin | To determine the MTD of Abraxane given every 3 weeks with carboplatin given on day 1 of a 21 day cycle | 21 days | 
| Sequence-dependent toxicity | To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific