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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307255
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : April 4, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: gemcitabine hydrochloride Drug: paclitaxel albumin-stabilized nanoparticle formulation Phase 1

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
Study Start Date : August 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: gemcitabine hydrochloride
    1000 mg/m2 on days 1 and 8 of each 21 day cycle
    Other Name: Gemzar
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
    260 mg/m2 to 340 mg/m2 (dose will depend on when subject enters the study). Paclitaxel will be given on day 1 of each 21 day cycle (every 3 weeks)
    Other Name: Abraxane

Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: 21 days ]
    Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)

  2. Maximum Tolerated Dose(MTD) [ Time Frame: 1 year ]
    If greater than or equal to 2 of 6 patients (33%) experience a DLT, then that dose level will be considered to have excessive toxicity and will = MTD

Secondary Outcome Measures :
  1. Radiographic Response to Treatment [ Time Frame: every 42 days ]
    Radiographic response will be measured and evaluated using RECIST criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307255

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United States, North Carolina
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00307255    
Other Study ID Numbers: LCCC 0520
CDR0000550136 ( Other Identifier: PDQ number )
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
unspecified adult solid tumor
protocol specific
Phase I
Additional relevant MeSH terms:
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Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs