Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI CALGB-30406 CALGB-30406, NCT00126581

Special Category: NCI Web site featured trial

Objectives

Primary

1. Determine the progression-free survival of patients with chemotherapy-naïve select stage IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without carboplatin and paclitaxel.

Secondary

1. Determine the radiographic response rate in patients treated with these regimens.
2. Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras mutations with the response rate and time to progression in patients treated with these regimens.
3. Determine the median and overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary non-small cell lung cancer (NSCLC)
  • Adenocarcinoma histology, including any of the following histologic variants:
    • Pure or mixed bronchoalveolar cell carcinoma
    • Adenosquamous cell carcinoma
  • No NSCLC not otherwise specified



• Pathology block or unstained slides from initial or subsequent diagnosis available
  • At least a core biopsy required
  • Fine needle aspirate alone is not sufficient



• Meets 1 of the following stage criteria:
  • Select stage IIIB disease with cytologically documented malignant pleural or pericardial effusion
  • Stage IV disease



• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • The following are considered non-measurable disease:
    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural or pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Abdominal masses not confirmed and followed by imaging techniques
    • Cystic lesions



• Meets 1 of the following criteria for smoking history:
  • Non-smoker, defined as a person who smoked ≤ 100 cigarettes in their lifetime
  • Former light smoker, defined as a person who smoked ≤ 10 pack years AND quit smoking ≥ 1 year ago



• No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requires corticosteroids)

Prior/Concurrent Therapy:

Biologic therapy

• No prior trastuzumab (Herceptin®) or cetuximab

Chemotherapy

• No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• No concurrent hormonal therapy except for the following:
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Steroids for adrenal failure
  • Intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel hypersensitivity reactions

Radiotherapy

• At least 3 weeks since prior radiotherapy, including cranial irradiation
• No concurrent radiotherapy, including palliative radiotherapy

Surgery

• At least 3 weeks since prior major surgery
• No prior significant surgical resection of the stomach or small bowel

Other

• No prior erlotinib, gefitinib, or lapatinib
• No other prior treatment targeting the HER family axis
• More than 4 weeks since prior and no other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL

Gastrointestinal

• Able to swallow tablets intact or dissolved in water
• No dysphagia
• No active gastrointestinal disease or disorder that would alter gastrointestinal motility or absorption
• No lack of integrity of the gastrointestinal tract

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years.

Outcomes

Progression-free survival (PFS) rate at 18 weeks

Response rate
Median and overall survival rate
Correlation of response with presence or absence of epidermal growth factor receptor (EGFR) mutations
PFS in presence or absence of EGFR mutations
Correlation of response and PFS in presence or absence of K-ras mutations
Toxicity

Outline

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

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



• Arm II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.

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

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Pasi Janne, MD, PhD, Protocol chair		Ph: 617-632-6076; 866-790-4500 Email: pjanne@partners.org
Vincent Miller, MD, Protocol co-chair		Ph: 212-639-7243; 800-525-2225 Email: millerv@mskcc.org

U.S.A.
California
	Castro Valley
	East Bay Radiation Oncology Center
		James Feusner, MD	Ph:  510-428-3689
	Eden Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Castro Valley
		James Feusner, MD	Ph:  510-428-3689
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus	Ph:  510-204-1414
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Highland General Hospital
		James Feusner, MD	Ph:  510-428-3689
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Pleasanton
	Valley Care Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Pleasanton
		James Feusner, MD	Ph:  510-428-3689
	San Diego
	Kaiser Permanente Medical Office -Vandever Medical Office
		Han Koh	Ph:  619-528-2596
	Veterans Affairs Medical Center - San Diego
		Barbara Parker	Ph:  858-552-8585
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
Connecticut
	Middletown
	Middlesex Hospital Cancer Center
		Mark Kimmel, MD	Ph:  860-358-2220
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Rogerio Lilenbaum, MD	Ph:  305-535-3310
Georgia
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Stephen Grubbs, MD	Ph:  410-398-4000
Massachusetts
	Boston
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Clinical Trials Office - Dana-Farber/Harvard Cancer Center	Ph:  617-582-8480
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
	Hyannis
	Cape Cod Hospital
		Pasi Janne, MD, PhD	Ph:  508-771-1800
	Lowell
	Lowell General Hospital
		Pasi Janne, MD, PhD	Ph:  978-937-6000
	Peabody
	NSMC Cancer Center - Peabody
		Pasi Janne, MD, PhD	Ph:  978-977-3434
	South Weymouth
	South Shore Hospital
		Pasi Janne, MD, PhD	Ph:  781-340-8000
Michigan
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-4894
	Veterans Affairs Medical Center - Columbia (Truman Memorial)
		Michael Perry, MD	Ph:  573-882-4979
	Saint Louis
	Arch Medical Services, Incorporated at Center for Cancer Care and Research
		Alan Lyss, MD	Ph:  314-628-1210
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5569 800-392-0936
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Ramaswamy Govindan, MD	Ph:  314-362-4819
Nebraska
	Grand Island
	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
		Margaret Kessinger, MD	Ph:  308-398-5450 800-998-2119
	North Platte
	Callahan Cancer Center at Great Plains Regional Medical Center
		Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center	Ph:  308-696-7864
	Omaha
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-383-2000
New Hampshire
	Nashua
	Oncology Center at St. Joseph Hospital
		Douglas Tisdale	Ph:  603-882-3000
New Jersey
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Manhasset
	CCOP - North Shore University Hospital
		Bhoomi Mehrotra, MD	Ph:  718-470-8930
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
	New Hyde Park
	Long Island Jewish Medical Center
		Bhoomi Mehrotra, MD	Ph:  718-470-8930
	New York
	Memorial Sloan-Kettering Cancer Center
		Vincent Miller, MD	Ph:  212-639-2000 800-525-2225
	Ralph Lauren Center for Cancer Care and Prevention
		Vincent Miller, MD	Ph:  212-987-1777
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200 ext. 201
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
Oklahoma
	Oklahoma City
	Cancer Care Associates - Mercy Campus
		Howard Ozer, MD, PhD	Ph:  405-271-4022
	Oklahoma University Cancer Institute
		Howard Ozer, MD, PhD	Ph:  405-271-4022
Rhode Island
	Pawtucket
	Memorial Hospital of Rhode Island
		Humera Khurshid	Ph:  401-729-2000
	Providence
	Miriam Hospital
		Clinical Trials Office - Miriam Hospital	Ph:  401-793-2224
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Charleston
	Roper St. Francis Cancer Center at Roper Hospital
		James Orcutt, MD	Ph:  843-577-2276
	Florence
	McLeod Regional Medical Center
		Clinical Trials Office - McLeod Regional Medical Center	Ph:  843-679-7256
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-241-6251
Vermont
	Berlin
	Mountainview Medical
		George Sanders	Ph:  802-223-6196
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Randomized Study of OSI-774 (ERLOTINIB) (NSC #718781; IND#63, 383) With or Without Carboplatin/Paclitaxel in Patients with Previously Untreated Adenocarcinoma of the Lung who Never Smoked or were Former Light Smokers
Trial Start Date		2005-08-18
Trial Completion Date		2008-02-04 (estimated)
Registered in ClinicalTrials.gov		NCT00126581
Date Submitted to PDQ		2005-06-10
Information Last Verified		2008-09-18
NCI Grant/Contract Number		CA31946

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