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Last Modified: 10/5/2008     First Published: 7/23/2005  
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Drug Information from MedlinePlus
Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase II Randomized Study of Erlotinib With or Without Carboplatin and Paclitaxel in Patients With Chemotherapy-Naïve Select Stage IIIB 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

Trial Description

Purpose:

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.

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

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive erlotinib by mouth once a day. Treatment may continue for as long as benefit is shown.

Patients in group two will receive erlotinib by mouth once a day for as long as benefit is shown. They will also receive a 1- to 3-hour infusion of paclitaxel and an infusion of carboplatin once in week 1. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to six courses.

Patients will be evaluated at least every 3 months for 1 year and every 6 months for up to 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

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

Trial Sites

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
  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
  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
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
  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
  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 2008-10-05
NCI Grant/Contract Number CA31946

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