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
  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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Carboplatin
Drug: Abraxane
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

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


Enrollment: 47
Study Start Date: December 2004
Study Completion Date: September 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Weekly Arm
Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
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
Experimental: Every 3 week Arm
Carboplatin day 1, abraxane day 1, every 21 day cycle
Drug: Carboplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
Other Name: Paraplatin
Drug: Abraxane
180mg/m2 - 340mg/m2, repeated every 21 days
Other Name: Paclitaxil
Experimental: Arm C
Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
Drug: Carboplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
Other Name: Paraplatin
Drug: Abraxane
100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle
Other Name: Paclitaxil

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520000

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00520000     History of Changes
Obsolete Identifiers: NCT00254098
Other Study ID Numbers: LCCC0412, CDR0000561620
Study First Received: August 21, 2007
Last Updated: March 5, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014