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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00307255
First received: March 24, 2006
Last updated: April 2, 2012
Last verified: April 2012

March 24, 2006
April 2, 2012
August 2006
September 2007   (final data collection date for primary outcome measure)
  • Dose Limiting Toxicity (DLT) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
  • Maximum Tolerated Dose(MTD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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
  • Toxicity will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
  • Toxicity endpoints:
Complete list of historical versions of study NCT00307255 on ClinicalTrials.gov Archive Site
Radiographic Response to Treatment [ Time Frame: every 42 days ] [ Designated as safety issue: No ]
Radiographic response will be measured and evaluated using RECIST criteria.
  • Efficacy endpoints:
  • An evaluation of response by the RECIST criteria24 after 2 cycles of gemcitabine and Abraxane.
  • Patients who have tumor markers (e.g. CA-125, PSA, and CEA) may be evaluated by tumor marker response as well.
Not Provided
Not Provided
 
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00307255
LCCC 0520, CDR0000550136
Not Provided
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP