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A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Carboplatin and Abraxane in Patients With 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Abraxane

Outcome Description:

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

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Thomas E. Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC0412

NCT ID:

NCT00520000

Start Date:

December 2004

Completion Date:

September 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

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