Know Cancer

forgot password

A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer



- 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.


- 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.

- 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.

Inclusion Criteria


- 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

- Brain metastasis allowed provided it has been treated and determined to be controlled
by the treating physician

- No IgE cetuximab antibody


- 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

- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone

Outcome Description:

Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.

Outcome Time Frame:

42 days

Safety Issue:


Principal Investigator

Thomas E. Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

LCCC 0816



Start Date:

July 2009

Completion Date:

November 2009

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms