Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085501

Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy.

PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: cetuximab Drug: paclitaxel	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Response rate (confirmed and unconfirmed, complete and partial response) [ Designated as safety issue: No ]
Toxic effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response [ Designated as safety issue: No ]

Study Start Date:

July 2004

Detailed Description:

OBJECTIVES:

Primary

Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and cetuximab.
Compare response rates (confirmed and unconfirmed, complete and partial) in patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.

Secondary

Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity.
Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2 hours on week 13 only) once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 9 months.

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 (NSCLC) of one of the following stages:
- Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0)
- Newly diagnosed stage IV disease (any T, any N, M1)
- Recurrent stage IV disease after prior surgery or radiotherapy
The following subtypes are eligible:
- Adenocarcinoma
- Squamous cell carcinoma
- Large cell carcinoma
- Unspecified
Measurable disease by CT scan, MRI, x-ray, or physical exam
- Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease
- Not within prior radiotherapy field unless a new lesion is present
- Not within area of prior surgical resection
No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 mg/dL

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
SGOT or SGPT ≤ 2 times ULN
Alkaline phosphatase ≤ 2 times ULN
No known acute hepatitis

Renal

Creatinine ≤ ULN
Creatinine clearance ≥ 50 mL/min

Cardiovascular

No significant cardiac disease
No uncontrolled hypertension
No unstable angina
No congestive heart failure

Other

No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
No active or uncontrolled infection
No sensory neuropathy ≥ grade 2
No known human anti-mouse antibodies
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic therapy for NSCLC
No prior chimeric or murine monoclonal antibody therapy
No prior cetuximab

Chemotherapy

No prior systemic chemotherapy for NSCLC

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered

Surgery

See Disease Characteristics
At least 2 weeks since prior thoracic or major surgery and recovered

Other

No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085501

Show 163 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Roy S. Herbst, MD, PhD	M.D. Anderson Cancer Center
Investigator:	Karen Kelly, MD	University of Colorado at Denver and Health Sciences Center
Investigator:	David R. Gandara, MD	University of California, Davis

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA Jr, Varella-Garcia M, Gandara DR. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol. 2008 Jul 10;26(20):3351-7.

Herbst RS, Chansky K, Kelly K, et al.: A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342. [Abstract] J Clin Oncol 25 (Suppl 18): A-7545, 395s, 2007.

Kelly K, Herbst RS, Crowley JJ, et al.: Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): a randomized phase II selectional trial SWOG 0342. [Abstract] J Clin Oncol 24 (Suppl 18): A-7015, 367s, 2006.

Study ID Numbers:	CDR0000370806, SWOG-S0342
Study First Received:	June 10, 2004
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00085501
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

adenocarcinoma of the lung
squamous cell lung cancer
large cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Cetuximab
Carboplatin
Recurrence
Carcinoma
Adenocarcinoma of lung

Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009