|
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical research trials and Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer  Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
For Condition: squamous cell lung cancer,bronchoalveolar cell lung cancer,adenocarcinoma of the lung,large cell lung cancer,adenosquamous cell lung cancer,Non-small cell lung cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of carboplatin, paclitaxel, and radiation therapy with or without thalidomide in treating patients who have newly diagnosed stage III non-small cell lung cancer.
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 day 1. Treatment continues for a second course beginning on day 22 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. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoanSchiller, Study Chair, University of Wisconsin Comprehensive Cancer Center
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
Additional Information:
Study ID Numbers: CDR0000067510; ECOG-3598
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004859
Other Squamous Cell Lung Cancer Studies:
1. Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
2. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
3. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
4. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
5. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
Related Studies:
Other squamous cell lung cancer Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
|
|
|
|
|
|
|
|
