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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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