S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661193
• Other study ID #: CDR0000593575
• Secondary ID: S0709U10CA032102
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: December 2016

Study information

• Verified date: February 2020
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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 untreated brain metastases

• Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids

• Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin
given IV
• erlotinib hydrochloride
given orally
• paclitaxel
given IV

Locations

Country	Name	City	State
United States	Harrington Cancer Center	Amarillo	Texas
United States	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	Kaiser Permanente - Deer Valley	Antioch	California
United States	Randolph Hospital	Asheboro	North Carolina
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Highline Medical Center Cancer Center	Burien	Washington
United States	Peninsula Medical Center	Burlingame	California
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Danville Regional Medical Center	Danville	Virginia
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Kaiser Permanente - Fremont	Fremont	California
United States	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Hays Medical Center	Hays	Kansas
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii
United States	Hutchinson Hospital Corporation	Hutchinson	Kansas
United States	Swedish Medical Center - Issaquah Campus	Issaquah	Washington
United States	Foote Memorial Hospital	Jackson	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Kansas City Cancer Centers - North	Kansas City	Missouri
United States	Kansas City Cancer Centers - South	Kansas City	Missouri
United States	Kansas City Cancer Centers - West	Kansas City	Kansas
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Kansas City Cancer Centers - East	Lee's Summit	Missouri
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia
United States	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California
United States	Mountain States Tumor Institute - Meridian	Meridian	Idaho
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	Saint Luke's Mountain States Tumor Institute	Nampa	Idaho
United States	Sutter Health - Western Division Cancer Research Group	Novato	California
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Epic Care - Oakland	Oakland	California
United States	Highland General Hospital	Oakland	California
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Kansas City Cancer Centers - Southwest	Overland Park	Kansas
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Mount Carmel Regional Cancer Center	Pittsburg	Kansas
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington
United States	Kaiser Permanente Medical Center - Redwood City	Redwood City	California
United States	Kaiser Permanente Medical Center - Richmond	Richmond	California
United States	Kaiser Permanente Medical Center - Roseville	Roseville	California
United States	Kaiser Permanente Medical Center - Sacramento	Sacramento	California
United States	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Kaiser Foundation Hospital - San Rafael	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California
United States	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington
United States	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas
United States	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Evergreen Hematology and Oncology, PS	Spokane	Washington
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Kaiser Permanente Medical Facility - Stockton	Stockton	California
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	Veterans Affairs Medical Center - Topeka (O'Neil)	Topeka	Kansas
United States	Tahoe Forest Cancer Center	Truckee	California
United States	Mountain States Tumor Institute at St. Luke's	Twin Falls	Idaho
United States	Kaiser Permanente Medical Center - Vacaville	Vacaville	California
United States	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Sutter Solano Medical Center	Vallejo	California
United States	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		From date of registration to 3 years or death, whichever comes first
Secondary	Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	From date of registration to 3 years or death, whichever comes first