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

Primary Purpose

Lung Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

cetuximab

carboplatin

ixabepilone

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

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

Radigoraphic response of measurable disease will be assessed using RECIST critera

Overall survival

Radigoraphic response of measurable disease will be assessed using RECIST criteria

Number of subjects experiencing adverse events

Adverse events will be assessed (graded) using CTCAE criteria

Full Information

NCT ID

NCT00998101

First Posted

October 17, 2009

Last Updated

March 5, 2012

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00998101

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study was withdrawn due issuses related to the science

Study Start Date

July 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

AUC=6 Day 1 of treatment over 30 minutes every 21 days

Intervention Type

Drug

Intervention Name(s)

ixabepilone

Intervention Description

30 mg/m2 , Day 1 over 3 hours every 21 days

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

42 days

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Radigoraphic response of measurable disease will be assessed using RECIST critera

Time Frame

2 years

Title

Overall survival

Description

Radigoraphic response of measurable disease will be assessed using RECIST criteria

Time Frame

4 years

Title

Number of subjects experiencing adverse events

Description

Adverse events will be assessed (graded) using CTCAE criteria

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas E. Stinchcombe, MD

Organizational Affiliation

UNC Lineberger Comprehensive Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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