Clinical trial NCT00307255: Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
Official title: Phase I Trial of Abraxane in Combination With Gemcitabine 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
Paclitaxel
Abraxane
Gemcitabine
Gemzar
Phase I
Lineberger
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-03-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: 21 days
measure: Maximum Tolerated Dose(MTD)
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic Response to Treatment
timeFrame: every 42 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Thomas E. Stinchcombe, MD
role: PRINCIPAL_INVESTIGATOR
References: