NCT00520000

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2004

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

August 21, 2007

Last Update Submit

March 5, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Weekly Arm

ACTIVE COMPARATOR

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

Drug: CarboplatinDrug: Abraxane

Every 3 week Arm

EXPERIMENTAL

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

Drug: CarboplatinDrug: Abraxane

Arm C

EXPERIMENTAL

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

Drug: CarboplatinDrug: Abraxane

Interventions

CarboplatinDRUG

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

Also known as: Paraplatin
Arm CEvery 3 week ArmWeekly Arm
AbraxaneDRUG

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

Also known as: Paclitaxil
Weekly Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Symptomatic brain metastases
  • PATIENT CHARACTERISTICS:
  • 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
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CarboplatinAlbumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas E. Stinchcombe, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

December 1, 2004

Primary Completion

May 1, 2006

Study Completion

September 1, 2007

Last Updated

March 6, 2012

Record last verified: 2012-03