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

UNC Lineberger Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: paclitaxel albumin-stabilized nanoparticle formulation

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00307255

CDR0000550136 (Other Identifier)

LCCC 0520

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.

Full description

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 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.

Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients may be treated at the MTD.

After completion of study treatment, patients are followed at 30 days.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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