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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Unspecified Adult Solid Tumor, Protocol Specific
Intervention	Drug: Carboplatin Drug: Abraxane Drug: Abraxane Drug: Abraxane
Phase	Phase 1
Sponsor	UNC Lineberger Comprehensive Cancer Center
Responsible Party	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier	NCT00520000
First Received	August 21, 2007
Last Updated	March 5, 2012
Last verified	March 2012

Tracking Information[ + expand ][ + ]

First Received Date	August 21, 2007
Last Updated Date	March 5, 2012
Start Date	December 2004
Estimated Primary Completion Date	September 2007
Current Primary Outcome Measures	Maximum Tolerated Dose (MTD) of Abraxane [Time Frame: 28 days] [Designated as safety issue: No]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] [Designated as safety issue: No]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] [Designated as safety issue: No]To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
Official Title	A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
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.
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Unspecified Adult Solid Tumor, Protocol Specific
Intervention	Drug: Carboplatin standard dose of area under the curve (AUC) AUC of 6 in all arms Other Names: ParaplatinDrug: Abraxane 75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle Other Names: PaclitaxilDrug: Abraxane 180mg/m2 - 340mg/m2, repeated every 21 days Other Names: PaclitaxilDrug: Abraxane 100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle Other Names: Paclitaxil
Study Arm (s)	Active Comparator: Weekly Arm Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle Experimental: Every 3 week Arm Carboplatin day 1, abraxane day 1, every 21 day cycle Experimental: Arm C Carboplatin day 1, abraxane day 1, 8 every 21 day cycle

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	47
Estimated Completion Date	September 2007
Estimated Primary Completion Date	May 2006
Eligibility 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 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00520000
Other Study ID Numbers	LCCC0412
Has Data Monitoring Committee	Yes
Information Provided By	UNC Lineberger Comprehensive Cancer Center
Study Sponsor	UNC Lineberger Comprehensive Cancer Center
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
Verification Date	March 2012