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

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Mar 24, 2006

Keywords

ClinConnect Summary

OBJECTIVES:

Primary

* Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) in combination with gemcitabine hydrochloride in patients with advanced metastatic solid tumors.

Secondary

* Evaluate the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) IV over 30 minutes on day 1 followed by gemcitabine hydrochloride IV over 30...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically or cytologically confirmed solid tumors
• • Advanced metastatic disease
• • Measurable or evaluable disease
• * Must meet 1 of the following criteria:
• • Failed prior standard therapy
• • Not a candidate for standard therapy
• • Has a disease for which there is no defined standard therapy
• • No symptomatic brain metastases
• PATIENT CHARACTERISTICS:
• • ECOG functional status 0-2
• • Life expectancy ≥ 8 weeks
• • Absolute neutrophil count ≥ 1,500/mm\^3
• • Platelet count \> 100,000/mm\^3
• • Hemoglobin ≥ 9.0 g/dL
• • Bilirubin normal
• • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
• • AST and ALT ≤ 2.5 times ULN
• • Not pregnant or nursing
• • Negative pregnancy test
• • No prior anaphylactic reaction or severe allergic reaction to paclitaxel, docetaxel, or gemcitabine hydrochloride
• • No active infectious process that will require treatment with antibiotics for \> 4 weeks
• • No uncontrolled congestive heart failure
• • No symptomatic coronary artery disease or heart block
• • No myocardial infarction within the past 3 months
• • No peripheral neuropathy ≥ grade 2 from any cause
• PRIOR CONCURRENT THERAPY:
• • More than 3 weeks since prior chemotherapy, radiotherapy, or any other treatment
• • No prior radiotherapy to \> 25% of bone marrow
• • No prior nitrosoureas
• • No more than 6 prior courses of alkylating agents
• • No more than 2 prior courses of mitomycin C
• • No more than 3 prior courses of cytotoxic therapy for metastatic disease
• • No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during study course 1