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CompletedNCT00520000Updated Mar 6, 2012

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

A Phase 1 interventional study of Carboplatin and Abraxane in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-06.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 47 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    Weekly Arm

    Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle

    Drug: Carboplatin · Drug: Abraxane

  • Experimental
    Every 3 week Arm

    Carboplatin day 1, abraxane day 1, every 21 day cycle

    Drug: Carboplatin · Drug: Abraxane

  • Experimental
    Arm C

    Carboplatin day 1, abraxane day 1, 8 every 21 day cycle

    Drug: Carboplatin · Drug: Abraxane

Interventions

  • DrugCarboplatin

    standard dose of area under the curve (AUC) AUC of 6 in all arms

    Also known as: Paraplatin

  • DrugAbraxane

    75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle

    Also known as: Paclitaxil

  • DrugAbraxane

    180mg/m2 - 340mg/m2, repeated every 21 days

    Also known as: Paclitaxil

  • DrugAbraxane

    100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle

    Also known as: Paclitaxil

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 28 days

  2. 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

    Time frame: 21 days

  3. Sequence-dependent toxicity

    To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520000
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 23, 2007
Start date
Dec 2004
Primary completion
May 2006
Completion
Sep 2007
Last update
Mar 6, 2012

Study contacts

Thomas E. Stinchcombe, MD
principal investigator · UNC Lineberger Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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