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 ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Celgene Corporation
Information provided by (Responsible Party):
Greg Otterson, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00729612
First received: August 6, 2008
Last updated: September 27, 2013
Last verified: September 2013
  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
Genetic: protein expression analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response rate defined as complete or partial response as assessed by RECIST response criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be estimated with an exact binomial confidence interval.


Secondary Outcome Measures:
  • Progression free survival per RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be analyzed using a Kaplan-Meier methods.

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be analyzed using a Kaplan-Meier methods.

  • Incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Will be evaluated using descriptive statistics.


Enrollment: 63
Study Start Date: August 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (nab-paclitaxel, carboplatin)
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.
Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Genetic: protein expression analysis Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729612

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Greg Otterson
National Comprehensive Cancer Network
Celgene Corporation
Investigators
Principal Investigator: Gregory A. Otterson, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Greg Otterson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00729612     History of Changes
Other Study ID Numbers: OSU-08059, NCI-2011-03196
Study First Received: August 6, 2008
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014