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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: Abraxane; Drug: Carboplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00520000

CDR0000561620 (Other Identifier)

LCCC0412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Weekly Arm

Active Comparator group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Abraxane

Drug: Abraxane

Drug: Abraxane

Every 3 week Arm

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Abraxane

Drug: Abraxane

Drug: Abraxane

Arm C

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Abraxane

Drug: Abraxane

Drug: Abraxane