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Lung Cancer |
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Clinical Trial: Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer large cell lung cancer Non-small cell lung cancer Squamous Cell Lung Cancer | Drug: carboplatin Drug: paclitaxel Drug: thalidomide Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: growth factor antagonist therapy Procedure: radiation therapy | Phase III |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Carboplatin, Paclitaxel, and Chemoradiotherapy With or Without Thalidomide in Patients With Stage III Non-Small Cell Lung Cancer
Further Study Details:
OBJECTIVES:
- Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide.
- Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.
- Determine whether the inactivation of p16, DAP-kinase, MGMT, or TIMP-3 genes can be used to predict survival in these patients treated with this regimen.
- Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 21. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression.
- Arm II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral thalidomide daily beginning on day 1 for up to 24 months in the absence of disease progression. Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy 5 days a week for 6 weeks. Arm II patients continue oral thalidomide.
Patients are followed every 2 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 588 patients will be accrued for this study within 7 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma
- Squamous cell
- Adenocarcinoma
- Large cell undifferentiated
- Bronchoalveolar
- Non-small cell carcinoma not otherwise stated
- Unresectable stage IIIA
- Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on CT scans must have mediastinotomy or thoracoscopy to rule out resectability OR
- Stage IIIB disease without significant pleural effusion
- Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative
- Metastases to contralateral, mediastinal, or supraclavicular nodes allowed
- Bidimensionally measurable or evaluable disease
PATIENT CHARACTERISTICS: Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- WBC at least 4,000/mm OR
- Absolute neutrophil count at least 2,000/mm^3
Hepatic:
- Bilirubin normal
- SGOT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
- No serious cardiac arrhythmias requiring medication
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
- No other active malignancies
- No serious uncontrolled active infection
- No evidence of greater than grade 1 neuropathy by history or physical examination
- No history of seizure disorders
- No contraindication to daily low-dose (81 mg/day) aspirin
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Concurrent filgrastim (G-CSF) allowed for persistent neutropenia
Chemotherapy:
- At least 5 years since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to only area of measurable or active tumor
Surgery:
- See Disease Characteristics
Location and Contact Information
Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
Colorado
Boulder Community Hospital, Boulder, Colorado, 80301-9019, United States; Recruiting
John Thomas Fleagle, MD 303-440-2399
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, 80224, United States; Recruiting
Eduardo R. Pajon, MD 303-777-2663 erpajon@aol.com
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, 80501, United States; Recruiting
Robert Evan Fisher, MD 303-485-4132
Medical Center of Aurora - South Campus, Aurora, Colorado, 80012-0000, United States; Recruiting
Sami G. Diab, MD 303-418-7600
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, 80933, United States; Recruiting
Robert Lynn Sayre, MD 719-577-2555
Porter Adventist Hospital, Denver, Colorado, 80210, United States; Recruiting
David Trevarthen, MD 303-788-8675
Presbyterian - St. Luke's Medical Center, Denver, Colorado, 80218, United States; Recruiting
Robert M. Jotte, MD, PhD 303-388-4876
Rocky Mountain Cancer Centers - Denver Rose, Denver, Colorado, 80220, United States; Recruiting
Scot M. Sedlacek, MD 303-321-0302
Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado, 80229, United States; Recruiting
Alvin L. Otsuka, MD 303-386-7622 aotsuka@direcpc.com
Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States; Recruiting
Dennis Carter, MD 720-225-4200
St. Joseph Hospital, Denver, Colorado, 80218-1191, United States; Recruiting
Michael McLaughlin, MD 303-861-3302
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, 81004, United States; Recruiting
Marlow M. Sloan, MD 719-560-6000
Swedish Medical Center, Englewood, Colorado, 80112, United States; Recruiting
Marshall Davis, MD 303-788-5860
Illinois
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, 60521, United States; Recruiting
Elyse Cheryl Schneiderman, MD 630-654-1790
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Al Bowen Benson, MD, FACP 312-695-1382
Swedish-American Regional Cancer Center, Rockford, Illinois, 61104-2315, United States; Recruiting
Lori Kline, RN, BS 815-489-4413 lkline@swedishamerican.org
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, 60611-4494, United States; Recruiting
Timothy M. Kuzel, MD 312-469-3748
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Iowa
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Massachusetts
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
John K. Erban, MD 617-636-5147 jerban@tufts-nemc.org
Michigan
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
West Michigan Cancer Center, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 616-373-7488 rlord@wmcc.org
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Robert J. Dalton, MD 218-786-8364 rdalton@smdc.org
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Joseph Aisner, MD 732-235-7401 aisnerjo@umdnj.edu
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States; Recruiting
Richard J. Rosenbluth, MD 201-996-5917
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Joseph A. Sparano, MD 718-904-2555 jsparano@montefiore.org
Lipson Cancer and Blood Center at Rochester General Hospital, Rochester, New York, 14621, United States; Recruiting
Peter Bushunow, MD 585-922-4020 peter.bushunow@viahealth.org
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
Peter H. Wiernik, MD 718-920-9900 pwiernik@olmhs.org
North Dakota
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Preston D. Steen, MD 701-234-6298 prestonsteen@meritcare.com
Ohio
CCOP - Toledo Community Hospital, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer, MD 419-843-6147
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Edward G. Mansour, MD 216-778-4394 emansour@metrohealth.org
Pennsylvania
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, MD 570-271-6466
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Paul B. Gilman, MD 610-645-2494
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Paul B. Gilman, MD 610-645-2000 pgilman@pol.net
PinnacleHealth Regional Cancer Center at Polyclinic Hospital, Harrisburg, Pennsylvania, 17110, United States; Recruiting
Robert Alan Gordon, MD 717-782-6415 rgordon@pinnaclehealth.org
Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
David Horton Johnson, MD 615-343-9454 david.h.johnson@vanderbilt.edu
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Tarit Kumar Banerjee, MD, FACP 715-387-5511
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Gerald K. Bayer, MD 920-433-8889
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226-3596, United States; Recruiting
David H. Vesole, MD, PhD 414-805-4626 dvesole@bmt.mcw.edu
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792, United States; Recruiting
Minesh P. Mehta, MD 608-263-5009 mehta@humonc.wisc.edu
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Carlos Santiago Vallejos-Sologuren, MD 51-14-499-137 postmaster@inen.sld.pe
South Africa
Pretoria Academic Hospital, Pretoria, 0001, South Africa; Recruiting
Coenraad Frederick Slabber, MD 27-12-354-1054
Study chairs or principal investigators
Joan Hoff Schiller, MD, Study Chair, University of Wisconsin Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000067510; ECOG-3598; NCT00004859
Record last reviewed: March 2005
Last Updated: March 15, 2005
Record first received: March 7, 2000
ClinicalTrials.gov Identifier: NCT00004859
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 15, 2005
Record first received: March 7, 2000
ClinicalTrials.gov Identifier: NCT00004859
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Adding Chemotherapy to Radiation After Surgery Adds No Benefit in Lung Cancer (National Cancer Institute)
- Age Shouldn't Prevent Treatment for Lung Cancer (American Cancer Society)
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