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Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00729612
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, 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 II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Procedure: immunoenzyme technique
Procedure: immunohistochemistry staining method
Procedure: laboratory biomarker analysis
Procedure: protein expression analysis
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as defined by RECIST [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: August 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.

Secondary

  • To evaluate safety of this regimen in these patients.
  • To describe the overall survival of these patients.
  • To describe progression-free survival of these patients.

Tertiary Objectives

  • To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression profiles.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling.

After completion of study treatment, patients are followed periodically.

  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 advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Stage IIIB disease with malignant pleural effusion
    • Stage IV disease
    • Recurrent disease
  • Squamous cell histology allowed
  • Not eligible for curative treatment or treatment with bevacizumab
  • Measurable disease according to RECIST
  • Tumor (paraffin blocks or slides) must be available for correlative biomarker studies
  • No uncontrolled brain metastases (or leptomeningeal disease)

    • Controlled brain metastases allowed

      • Able to receive appropriate therapeutic radiotherapy
      • Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9.0 g/L
  • Total bilirubin ≤ 1.5 mg/dL
  • AST and ALT < 2.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mg/mL
  • No known HIV or hepatitis B or C
  • Not pregnant
  • Negative pregnancy test
  • Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation
  • Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy)
  • No cardiac disease, including any of the following:

    • NYHA class III-IV congestive heart failure
    • Unstable angina (angina symptoms at rest)
    • New onset angina (began within the past 3 months)
    • Myocardial infarction within the past 6 months
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
  • No peripheral neuropathy ≥ grade 2
  • No active clinically serious infection > CTCAE grade 2
  • No serious non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 4 weeks
  • No evidence or history of bleeding diathesis or coagulopathy
  • No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years

    • Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed
  • No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent therapeutic anticoagulation, > 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed
  • At least 14 days since prior and no concurrent radiotherapy
  • More than 4 weeks since prior major surgery or open biopsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729612

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Gregory A. Otterson, MD     866-627-7616     osu@emergingmed.com    
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Comprehensive Cancer Network
Investigators
Principal Investigator: Gregory A. Otterson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Principal Investigator: Gregory A. Otterson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Gregory A. Otterson )
Study ID Numbers: CDR0000602242, OSU-08059, NCCN-AO8
Study First Received: August 6, 2008
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00729612  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Carboplatin
Hemorrhage
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009