|
Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical research trials and Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer. Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer  Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
For Condition: adenocarcinoma of the lung,stage 4 non-small cell lung cancer,large cell lung cancer,squamous cell lung cancer,recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Southwest 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. PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer.
Details: OBJECTIVES: - Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2, when treated with sequential vinorelbine and docetaxel. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.) - Determine the objective tumor response rates, including confirmed and unconfirmed and complete and partial, in patients treated with this regimen. - Assess the dose delivered and the reported functional symptom status of patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients. OUTLINE: This is a multicenter study. Patients are stratified according to age and performance status (age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2). (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.) Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Beginning 2 weeks after the last dose of vinorelbine, patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of courses 2-6, and at week 22. Patients are followed at week 22, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A minimum of 95 patients (55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2) will be accrued for this study within 12-18 months. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed, newly diagnosed, advanced primary non-small cell lung cancer (NSCLC) (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified), designated as 1 of the following stages: - Selected stage IIIB (excluding Pancoast tumors) - T4 lesion due to malignant pleural effusion OR - Multiple lesions in a single lobe containing a T3 or T4 primary - Stage IV (any T, any N, M1) - Recurrent disease after prior surgery and/or radiotherapy - Measurable or evaluable disease outside of prior radiation port - No bronchoalveolar carcinoma - No brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-1 (for age 70 and over) (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003) - Zubrod 2 (for age 18 and over) Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT/SGPT no greater than 2 times ULN if alkaline phosphatase is no greater than ULN OR - Alkaline phosphatase no greater than 4 times ULN if SGOT/SGPT are no greater than ULN Renal: - Not specified Other: - No prior severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80 - No grade 2 or greater sensory neuropathy - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior or concurrent biologic therapy for NSCLC - No concurrent filgrastim (G-CSF) Chemotherapy: - No prior systemic chemotherapy for NSCLC Endocrine therapy: - No prior or concurrent hormonal therapy for NSCLC Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - Concurrent palliative radiotherapy to small-field nonmeasurable lesions (i.e., painful bony lesions) allowed - No other concurrent radiotherapy Surgery: - See Disease Characteristics - At least 3 weeks since prior thoracic or other major surgery and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulHesketh, Study Chair, St. Elizabeth's Medical Center
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Genesis Medical Center
Davenport, Iowa, 52804
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Additional Information:
Study ID Numbers: CDR0000068991; SWOG-S0027
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026156
Other Squamous Cell Lung Cancer Studies:
1. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
2. Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
3. Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
4. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
5. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other squamous cell lung cancer Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
