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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (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

August 21, 2007
March 5, 2012
December 2004
May 2006   (final data collection date for primary outcome measure)
  • 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
  • Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation given once in week 1 with carboplatin given once in week 1 with treatment repeated every 3 weeks
  • Sequence-dependent effects on toxicity and pharmacokinetics
  • Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation given once in weeks 1, 2, and 3 with carboplatin given once in week 1 with treatment repeated every 4 weeks
  • Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation given once in weeks 1 and 2 with carboplatin given once in week 1 with treatment repeated every 3 weeks
Complete list of historical versions of study NCT00520000 on ClinicalTrials.gov Archive Site
Not Provided
Antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation given once weekly or once every 3 weeks
Not Provided
Not Provided
 
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: Carboplatin
    standard dose of area under the curve (AUC) AUC of 6 in all arms
    Other Name: Paraplatin
  • Drug: Abraxane
    75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle
    Other Name: Paclitaxil
  • Drug: Abraxane
    180mg/m2 - 340mg/m2, repeated every 21 days
    Other Name: Paclitaxil
  • Drug: Abraxane
    100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle
    Other Name: Paclitaxil
  • Active Comparator: Weekly Arm
    Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
    Interventions:
    • Drug: Carboplatin
    • Drug: Abraxane
  • Experimental: Every 3 week Arm
    Carboplatin day 1, abraxane day 1, every 21 day cycle
    Interventions:
    • Drug: Carboplatin
    • Drug: Abraxane
  • Experimental: Arm C
    Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
    Interventions:
    • Drug: Carboplatin
    • Drug: Abraxane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
September 2007
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00520000
LCCC0412, CDR0000561620
Yes
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP