Lung Cancer Clinical Trial
S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.
Full Description
OBJECTIVES:
Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel.
Determine the response rate in these patients when treated with this regimen.
Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.
At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIB non-small cell lung cancer
Adenocarcinoma
Large cell carcinoma
Squamous cell carcinoma
Pathologically or radiographically documented positive N3 nodes
No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR
T4 tumor invading any of the following:
Mediastinum
Heart
Great vessels
Trachea
Esophagus
Vertebral body
Carina
No brain, contralateral chest, liver, or adrenal metastases
No more than 1 parenchymal lesion
No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap
No pericardial effusions
Measurable disease
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Zubrod 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Not specified
Renal:
Creatinine clearance at least 50 mL/min
Pulmonary:
One of the following:
FEV1 at least 2.0 L
Predicted FEV1 of contralateral lung greater than 800 mL
Predicted post-treatment FEV1 at least 1.0 L
Other:
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent growth factors during induction chemoradiotherapy
Chemotherapy:
No prior chemotherapy for lung cancer
Endocrine therapy:
Not specified
Radiotherapy:
No prior radiotherapy for lung cancer
Surgery:
No prior surgical resection of lung cancer
Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed
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There are 87 Locations for this study
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Los Angeles California, 90073, United States
Los Angeles California, 90095, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80010, United States
Denver Colorado, 80220, United States
Washington District of Columbia, 20060, United States
Atlanta Georgia, 30342, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96859, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40502, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71130, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Royal Oak Michigan, 48073, United States
Southfield Michigan, 48075, United States
Duluth Minnesota, 55805, United States
Biloxi Mississippi, 39531, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27104, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45428, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97207, United States
Portland Oregon, 97225, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78284, United States
San Antonio Texas, 78284, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84148, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Seattle Washington, 98108, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98431, United States
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