Clinical trial NCT00520000: Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
Official title: A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Abraxane
timeFrame: 28 days
measure: Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin
timeFrame: 21 days
measure: Sequence-dependent toxicity
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Thomas E. Stinchcombe, MD
role: PRINCIPAL_INVESTIGATOR
References: