Erlotinib With or Without Carboplatin and Paclitaxel 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:	NCT00661193

Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: erlotinib hydrochloride Drug: paclitaxel	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2) Selected by Serum Proteomics

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

Primary Outcome Measures:

Selection of one of two treatment regimens (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further study in a phase III trial, based on median progression-free survival for ≥ 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate (confirmed and unconfirmed, complete and partial response) in a subset of patients with measurable disease [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	December 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: erlotinib hydrochloride given orally
Arm II: Active Comparator Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: carboplatin given IV Drug: erlotinib hydrochloride given orally Drug: paclitaxel given IV

Arms

Assigned Interventions

Arm I: Active Comparator

Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride

given orally

Arm II: Active Comparator

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: carboplatin

given IV

Drug: erlotinib hydrochloride

given orally

Drug: paclitaxel

given IV

Detailed Description:

OBJECTIVES:

Primary

To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further testing against standard treatment, based on median progression-free survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer with a Zubrod performance status of 2.

Secondary

To assess the feasibility of selecting patients for a trial based on central EGFR testing of serum in a cooperative group setting.
To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and partial response), in a subset of patients with measurable disease.

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

Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.

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), including any of the following subtypes:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unspecified
Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
- Selected stage IIIB disease (T4 [secondary to malignant pleural effusion only], any N, M0)
- Stage IV disease (any T, any N, M1 [distant metastases present])
Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
- The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
- Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
No known brain metastases by CT scan or MRI of the brain

PATIENT CHARACTERISTICS:

Zubrod performance status 2
ANC ≥ 1,500/mm³
Platelet count ≥ 1,000/mm³
Serum bilirubin normal
SGOT or SGPT normal
Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
Willing to provide prior smoking history as requested on the prestudy form
No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
No malabsorption syndrome or requirement for IV alimentation
No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
No significant history of cardiac disease, including any of the following:
- Uncontrolled high blood pressure
- Unstable angina
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmia requiring medication
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
At least 1 year since prior adjuvant chemotherapy
No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
No prior EGFR inhibitors
No prior surgical procedures affecting absorption
No concurrent major surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661193

Locations

United States, Kansas
Tammy Walker Cancer Center at Salina Regional Health Center	Recruiting
Salina, Kansas, United States, 67401
Contact: William F. Cathcart-Rake, MD 785-452-4860

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Primo N. Lara, MD	University of California, Davis
Investigator:	Paul J. Hesketh, MD	Caritas St. Elizabeth's Medical Center of Boston

More Information

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

Study ID Numbers:	CDR0000593575, SWOG-S0709
Study First Received:	April 17, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00661193
Health Authority:	Unspecified

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
large cell lung cancer
squamous cell lung cancer

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
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 by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents

Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009