Lung Cancer Clinical Trial

S9712: Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy consisting of carboplatin, etoposide and paclitaxel in treating patients with newly diagnosed stage III non-small cell lung cancer.

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Full Description

OBJECTIVES: I. Assess the survival and failure-free survival in poor risk patients with stage IIIA or IIIB non-small cell lung carcinoma treated with concurrent radiation, carboplatin, and etoposide followed by consolidation with paclitaxel. II. Evaluate the response and toxicities associated with this regimen in this group of poor risk patients.

OUTLINE: This is nonrandomized study. Chemotherapy on cycle 1 starts on day 1 with concurrent initiation of radiotherapy. Chemotherapy is given prior to radiotherapy on those days when both treatments are given. Cycle 2 begins on day 29. Carboplatin is administered by 15 minute IV infusions on days 1, 3, 29, and 31. Etoposide (VP-16) is administered after carboplatin by 30 minute IV infusions on days 1-4, and 29-32. Radiation therapy begins within 24 hours of day 1, cycle 1 of chemotherapy. The primary tumor, the adjacent mediastinum, and other targeted lymph nodes are administered radiotherapy daily 5 days a week for 6.5 weeks. After the 2 cycles of chemotherapy and chest radiotherapy, patients who have stable disease, partial response, or complete response receive 3 cycles of paclitaxel. Paclitaxel is administered by 3 hour IV infusions starting 4 weeks after completion of chemotherapy and radiotherapy and repeated every 3-4 weeks (approximately days 71, 92, and 103) for a total of 3 cycles. Patients are followed every month for the first year, every 3 months for the second year, every 6 months for the third year, and then annually thereafter while on treatment. After treatment, patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: There will be 80 patients accrued in this study over 16 months.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed single primary bronchogenic non-small cell lung cancer (NSCLC) Stage IIIA (T1-2 N2 M0; T3 N0-2 M0) or IIIB (T4 or N3 M0, excluding malignant pleural effusion) Following NSCLC cellular types are eligible: adenocarcinoma large cell carcinoma squamous cell carcinoma unspecified Histology or cytology from involved mediastinal or supraclavicular nodes are sufficient for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on radiographs Radiographic evidence of mediastinal lymph nodes of at least 1.5 cm in the largest diameter is sufficient to stage N2 or N3 If the largest mediastinal nodes are less than 1.5 cm in diameter and this is the basis for stage III disease, then at least one of the nodes has to be proven positive cytologically or histologically No bronchioloalveolar carcinoma or stage IIIB tumor involving the superior sulcus Patients must meet at least one of the following conditions: - FEV1 less than 2 liters and predicted FEV1 of the contralateral lung no greater than 800 mL based on the quantitative split function testing - Creatinine clearance less than 50 mL/min - Significant clinical hearing loss and unwilling to accept the potential for worsening due to cisplatin - Controlled congestive heart failure that, in the opinion of the investigator, may become decompensated due to excessive hydration prior to cisplatin administration - SWOG performance status 2 and either albumin less than 0.85 times upper limit of normal or weight loss of greater than 10% due to tumor Measurable or evaluable disease Patients with pleural effusion are eligible only if: - pleural fluid must be a transudate with negative cytology if present before mediastinoscopy or exploratory thoracotomy - pleural fluid can be either transudate or exudate with negative cytology if present only after exploratory or staging thoracotomy but not before - in any case, pleural effusion is present only on CT scan but not on decubitus chest x-ray, and it is deemed too small to tap under either CT or ultrasound guidance

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal SGOT no greater than 1.5 times upper limit of normal Renal: Creatinine clearance at least 20 mL/min Cardiovascular: No unstable congestive heart failure No active angina No unstable cardiac arrhythmias Pulmonary: FEV1 at least 1.0 liter Also See Disease Characteristics Other: No uncontrolled peptic ulcer disease No active infection No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years Not pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation for lung cancer Surgery: No prior surgery for lung cancer

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

96

Study ID:

NCT00003158

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 77 Locations for this study

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MBCCOP - University of South Alabama
Mobile Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock Arkansas, 72205, United States
Beckman Research Institute, City of Hope
Duarte California, 91010, United States
Veterans Affairs Medical Center - Long Beach
Long Beach California, 90822, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
University of Colorado Cancer Center
Denver Colorado, 80262, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
CCOP - Central Illinois
Springfield Illinois, 62526, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40511, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
MBCCOP - LSU Medical Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans Louisiana, 70112, United States
Louisiana State University Hospital - Shreveport
Shreveport Louisiana, 71130, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71130, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor Michigan, 48105, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids Michigan, 49503, United States
Providence Hospital - Southfield
Southfield Michigan, 48075, United States
Veterans Affairs Medical Center - Biloxi
Biloxi Mississippi, 39531, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler AFB Mississippi, 39534, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Missouri, 64128, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
St. Louis University Health Sciences Center
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque New Mexico, 87131, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn New York, 11209, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45219, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Cleveland Clinic Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Kettering Ohio, 45429, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City Oklahoma, 73104, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland Oregon, 97201, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Texas Tech University Health Science Center
Lubbock Texas, 79423, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84132, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
CCOP - Northwest
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

96

Study ID:

NCT00003158

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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