Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

March 6, 2018 updated by: Greg Otterson

Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (Eastern Cooperative Oncology Group) performance status 0-2
  • ANC (absolute neutrophil count) ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9.0 g/L
  • Total bilirubin ≤ 1.5 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 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 (New York Heart Association) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Drug: paclitaxel albumin-stabilized nanoparticle formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.
Time Frame: Up to 5 years
Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Up to 5 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Up to 5 years
Overall Survival
Time Frame: Up to 5 years
Will be analyzed using a Kaplan-Meier methods.
Up to 5 years
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0
Time Frame: Up to 5 years
The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greg Otterson

Collaborators

Celgene Corporation
National Comprehensive Cancer Network

Investigators

  • Principal Investigator: Gregory A. Otterson, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2008

Primary Completion (Actual)

December 16, 2011

Study Completion (Actual)

December 16, 2011

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-08059
  • NCI-2011-03196 (Registry Identifier: Clinical Trials Reporting Program (CTRP))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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