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Sunitinib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Alternate Title Basic Trial Information Trial Description Purpose Eligibility Treatment/Intervention Trial Contact Information Registry Information
Alternate Title
Phase I/II Study of Sunitinib Malate, Cisplatin, and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II, Phase I | Treatment | Active | 18 and over | CALGB-30504 CALGB 30504, NCT00453154 |
Trial Description Purpose: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with cisplatin and etoposide may kill more tumor cells.
This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cisplatin and etoposide and to see how well they work in treating patients with extensive-stage 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: Some patients will receive an infusion of cisplatin on day 1 and an infusion of etoposide on days 1-3. They will also receive sunitinib by mouth once a day for 2 weeks. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive sunitinib alone by mouth once a day for as long as benefit is shown. Patients will receive an infusion of cisplatin on day 1, an infusion of etoposide on days 1-3, and sunitinib by mouth once a day for 2 weeks. Treatment with cisplatin, etoposide, and sunitinib may repeat every 3 weeks for up to six courses. Some patients will be randomly assigned (have and equal chance of being placed) to one of two treatment groups. Patients in group one will receive sunitinib by mouth once a day on day 1 for as long as benefit is shown. Patients in group two will receive placebo by mouth once a day on day 1 for as long as benefit is shown. After finishing treatment, patients will be evaluated every 3 months for 1 year and every 6 months for 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 ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Neal Ready, MD, PhD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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U.S.A. |
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California |
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San Francisco |
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| | | | | | | | UCSF Helen Diller Family Comprehensive Cancer Center |
| | Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center | |
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Delaware |
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Lewes |
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| | | Tunnell Cancer Center at Beebe Medical Center |
| | Clinical Trials Office - Tunnell Cancer Center | |
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Newark |
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| | CCOP - Christiana Care Health Services |
| | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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Georgia |
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Savannah |
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| | | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center |
| | Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute | |
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Illinois |
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Chicago |
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| | | University of Chicago Cancer Research Center |
| | Clinical Trials Office - University of Chicago Cancer Research Center | |
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La Grange |
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| | La Grange Memorial Hospital |
| | Clinical Trials Office - La Grange Memorial Hospital | |
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Indiana |
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Elkhart |
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| | | Elkhart General Hospital |
| | Rafat Ansari, MD, FACP | |
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Kokomo |
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| | Howard Community Hospital |
| | Rafat Ansari, MD, FACP | |
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La Porte |
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| | Center for Cancer Therapy at LaPorte Hospital and Health Services |
| | Rafat Ansari, MD, FACP | |
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South Bend |
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| | CCOP - Northern Indiana CR Consortium |
| | Rafat Ansari, MD, FACP | |
| | Memorial Hospital of South Bend |
| | Clinical Trials Office - Memorial Hospital of South Bend | |
| | Saint Joseph Regional Medical Center |
| | Rafat Ansari, MD, FACP | |
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Iowa |
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Iowa City |
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| | | Holden Comprehensive Cancer Center at University of Iowa |
| | Cancer Information Service | |
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Maryland |
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Elkton MD |
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| | | Union Hospital Cancer Program at Union Hospital |
| | Stephen Grubbs, MD | |
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Salisbury |
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| | Peninsula Regional Medical Center |
| | Clinical Trials Office - Peninsula Regional Medical Center | |
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Massachusetts |
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Gloucester |
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| | | Addison Gilbert Hospital |
| | Angus McIntyre, MD | |
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Michigan |
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St. Joseph |
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| | | Lakeland Regional Cancer Care Center - St. Joseph |
| | Rafat Ansari, MD, FACP | |
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Missouri |
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Saint Louis |
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| | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | Maria Baggstrom, MD | |
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Nebraska |
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Grand Island |
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| | | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center |
| | Apar Ganti | Ph: | 308-398-5450 | | 800-998-2119 |
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North Platte |
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| | Callahan Cancer Center at Great Plains Regional Medical Center |
| | Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center | |
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Omaha |
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| | Alegant Health Cancer Center at Bergan Mercy Medical Center |
| | Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center | |
| | CCOP - Missouri Valley Cancer Consortium |
| | Gamini Soori, MD, FACP, FRCP, MBA | |
| | Creighton University Medical Center |
| | Clinical Trials Office - Creighton University Medical Center | |
| | Immanuel Medical Center |
| | Gamini Soori, MD, FACP, FRCP, MBA | |
| | Methodist Estabrook Cancer Center |
| | Robert Langdon, MD | |
| | 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 | |
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New Hampshire |
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Concord |
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| | | New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care |
| | Charles Catcher, MD | |
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Hooksett |
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| | New Hampshire Oncology - Hematology, PA - Hooksett |
| | Charles Catcher, MD | |
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New Jersey |
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Voorhees |
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| | | Cancer Institute of New Jersey at Cooper - Voorhees |
| | Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees | |
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New York |
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Buffalo |
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| | | Roswell Park Cancer Institute |
| | Clinical Trials Office - Roswell Park Cancer Institute | |
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Glens Falls |
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| | Charles R. Wood Cancer Center at Glens Falls Hospital |
| | Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital | |
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New York |
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| | Memorial Sloan-Kettering Cancer Center |
| | Lee Krug, MD | |
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Syracuse |
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| | SUNY Upstate Medical University Hospital |
| | Clinical Trials Office - SUNY Upstate Medical University Hospital | |
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North Carolina |
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Durham |
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| | | Duke Comprehensive Cancer Center |
| | Clinical Trials Office - Duke Comprehensive Cancer Center | |
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Hendersonville |
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| | Pardee Memorial Hospital |
| | James Radford, MD | |
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Winston-Salem |
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| | Wake Forest University Comprehensive Cancer Center |
| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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Ohio |
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Columbus |
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| | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | Ohio State University Cancer Clinical Trial Matching Service | |
| Email:
osu@emergingmed.com |
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South Carolina |
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Florence |
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| | | McLeod Regional Medical Center |
| | Clinical Trials Office - McLeod Regional Medical Center | |
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Vermont |
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Berlin |
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| | | Mountainview Medical |
| | Steven Grunberg, MD | |
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Burlington |
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| | Fletcher Allen Health Care - University Health Center Campus |
| | Clinical Trials Office - Fletcher Allen Health Care | |
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Virginia |
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Danville |
![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) |
| | | Danville Regional Medical Center |
| | Clinical Trials Office - Danville Regional Medical Center | |
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Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | Combination Cisplatin, Etoposide and Sunitinib Malate (IND 74019; NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/II Study | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2007-03-15 | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2008-02-23 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00453154 | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2007-02-26 | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2009-05-07 | ![](https://webarchive.library.unt.edu/eot2008/20090510004615im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA31946 |
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