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

NCT ID: NCT00520000

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-09-30

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weekly Arm

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

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

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

Abraxane

Intervention Type: DRUG

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

Every 3 week Arm

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

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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

Abraxane

Intervention Type: DRUG

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

Arm C

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

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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

Abraxane

Intervention Type: DRUG

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

Interventions

Carboplatin

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

Intervention Type: DRUG

Abraxane

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

Intervention Type: DRUG

Abraxane

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

Intervention Type: DRUG

Abraxane

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

Intervention Type: DRUG

Other Intervention Names

Paraplatin; Paclitaxil; Paclitaxil; Paclitaxil

Eligibility Criteria

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

• 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

• Symptomatic brain metastases

PATIENT CHARACTERISTICS:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E. Stinchcombe, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

CDR0000561620

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC0412

Identifier Type: -

Identifier Source: org_study_id

NCT00254098

Identifier Type: -

Identifier Source: nct_alias