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
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Radiographic Response to Treatment [ Time Frame: every 42 days ] [ Designated as safety issue: No ]
    Radiographic response will be measured and evaluated using RECIST criteria.


Enrollment: 18
Study Start Date: August 2006
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307255

Locations
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
Investigators
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00307255     History of Changes
Other Study ID Numbers: LCCC 0520, CDR0000550136
Study First Received: March 24, 2006
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
unspecified adult solid tumor
protocol specific
Paclitaxel
Abraxane
Gemcitabine
Gemzar
Phase I
Lineberger

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 15, 2014