Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy

This study has been withdrawn prior to enrollment.
(Study was withdrawn due issuses related to the science)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00998101
First received: October 17, 2009
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.


Condition Intervention Phase
Lung Cancer
Drug: cetuximab
Drug: carboplatin
Drug: ixabepilone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Radigoraphic response of measurable disease will be assessed using RECIST critera

  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Radigoraphic response of measurable disease will be assessed using RECIST criteria

  • Number of subjects experiencing adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events will be assessed (graded) using CTCAE criteria


Enrollment: 0
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cetuximab
    400 mg/m2 Cycle 1 day 1 only over 120 minutes 250 mg/m2 Cycle 1 days 8,15 AND on all other cycles days 1,8,15 over 60 minutes
    Other Name: Erbitux
    Drug: carboplatin
    AUC=6 Day 1 of treatment over 30 minutes every 21 days
    Drug: ixabepilone
    30 mg/m2 , Day 1 over 3 hours every 21 days
Detailed Description:

OBJECTIVES:

Primary

  • To estimate the disease-control rate in patients with advanced chemotherapy-naive non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.

Secondary

  • To estimate the progression-free survival of patients treated with this regimen.
  • To estimate the overall survival of patients treated with this regimen.
  • To estimate the toxicity of this regimen in these patients.
  • To determine the potential predictive marker of efficacy of ixabepilone and cetuximab. (exploratory)
  • To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and cetuximab IV over 1-2 hours on days 1, 8 and 15. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

Tumor tissue and blood samples are collected for further analysis.

After completion of study therapy, 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 non-small cell lung cancer

    • Chemotherapy-naive
    • Stage IIIB disease not amenable to surgery with pleural effusion, pericardial effusion, or not a candidate for chemoradiotherapy
    • Stage IV disease
  • Must have pathology block or unstained slides from initial or subsequent diagnosis

    • Diagnosis made via a core biopsy (not a fine-needle aspirate) required
  • Measurable disease as defined by RECIST guidelines

    • For patient who received prior radiotherapy, evaluable disease must be outside of the radiation field, or have new lesions that developed within the radiation field
  • Brain metastasis allowed provided it has been treated and determined to be controlled by the treating physician
  • No IgE cetuximab antibody

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Creatinine < 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastasis)
  • Bilirubin ≤ 1.5 times ULN
  • Prior malignancy allowed provided the treating physician determines that the patient's life expectancy is best defined by diagnosis of non-small cell lung cancer (NSCLC)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2 by NCI CTCAE v. 3.0
  • No prior severe allergic reaction to any of the following:

    • Carboplatin
    • Taxane therapy
    • Monoclonal antibody
    • Hypersensitivity (NCI CTCAE grade3-4) to a drug formulated in Cremophor® EL (polyoxyethylated castor oil)
  • No active or uncontrolled infection
  • No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Uncontrolled congestive heart failure
    • Cardiomyopathy with decreased ejection fraction
  • No underlying interstitial lung disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 1 week since prior and no concurrent therapeutic radiotherapy

    • Palliative radiotherapy for painful bone lesions allowed
  • At least 6 months since prior adjuvant chemotherapy
  • No investigational agent(s) within the past 30 days
  • Not requiring concurrent treatment with any of the following:

    • Ketoconazole
    • Itraconazole
    • Ritonavir
    • Amprenavir
    • Indinavir
    • Nelfinavir
    • Delavirdine
    • Voriconazole
  • No other concurrent chemotherapy or cetuximab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998101

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

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00998101     History of Changes
Other Study ID Numbers: LCCC 0816, P30CA016086, CDR0000656960
Study First Received: October 17, 2009
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small 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
Cetuximab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014