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Home > "R" Clinical Trials Conditions > Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer



Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

For Condition: Non-small cell lung cancer
Status: Suspended
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage I-IIIB non-small cell lung cancer (phase I). - Determine the 12-month survival rate in patients treated with this regimen (phase II). - Determine the toxicity of this regimen in these patients. - Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen. - Determine the complete response rate in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy. - Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 5-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. - Phase II: Additional patients are accrued and treated as above at the MTD. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I and 46 for phase II) will be accrued for this study within 1 year.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable stage I-IIIB non-small cell lung cancer - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma - Non-small cell carcinoma not otherwise specified - All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields - Measurable disease on 3-dimensional planning CT scan - No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma - No stage IV or recurrent disease - No distant metastases or supraclavicular lymph node involvement - No significant atelectasis (i.e., atelectasis of an entire lung) - No pleural effusions, pericardial effusions, or superior vena cava syndrome - No prior lung cancer within the past 2 years - Ineligible for currently open RTOG phase III lung protocols PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - AST less than 2 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Pulmonary: - FEV_1 at least 1.0 L Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No weight loss greater than 5% in the past 6 months - No other malignancy within the past year except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic response modifiers for current lung cancer - At least 5 years since prior biologic response modifiers Chemotherapy: - No prior chemotherapy for current lung cancer - At least 5 years since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the thorax Surgery: - No prior complete tumor resection
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JeffreyBradley,  Study Chair,  Washington University Siteman Cancer Center

University of Texas Medical Branch
Galveston,  Texas,  77555-0209
United States
 

Siteman Cancer Center
St. Louis,  Missouri,  63110
United States
 

Latter Day Saints Hospital
Salt Lake City,  Utah,  84143
United States
 

Northridge Hospital Medical Center
Northridge,  California,  91328
United States
 

Gulf Coast Cancer Treatment Center
Panama City,  Florida,  32405-4587
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 

Methodist Medical Center of Illinois
Peoria,  Illinois,  61636
United States
 

Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

Joe Arrington Cancer Research and Treatment Center
Lubbock,  Texas,  79410-1894
United States
 

Gundersen Lutheran Medical Foundation
La Crosse,  Wisconsin,  54601
United States
 

University of Louisville
Louisville,  Kentucky,  40292
United States
 

Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee,  Wisconsin,  53295
United States
 

Utah Valley Regional Medical Center - Provo
Provo,  Utah,  84604
United States
 

Delaware County Memorial Hospital
Drexel Hill,  Pennsylvania,  19026
United States
 

McKay-Dee Hospital Center
Ogden,  Utah,  84403
United States
 

CCOP - Marshfield Clinic Research Foundation
Marshfield,  Wisconsin,  54449
United States
 

Radiation Medical Group, Incorporated
San Diego,  California,  92101
United States
 

CCOP - Bay Area Tumor Institute
Oakland,  California,  94609-3305
United States
 

Cross Cancer Institute
Edmonton,  Alberta,  T6G 1Z2
Canada
 

Dixie Regional Medical Center
St. George,  Utah,  84770
United States
 

Albert Einstein Cancer Center
Philadelphia,  Pennsylvania,  19141-3098
United States
 

Foundation for Cancer Research and Education
Phoenix,  Arizona,  85013
United States
 

Akron City Hospital - Summa Health System
Akron,  Ohio,  44304
United States
 

University of Florida Health Science Center
Gainesville,  Florida,  32610-0385
United States
 

Cancer Care Center, Incorporated
Salem,  Ohio,  44460
United States
 

Akron General Medical Center
Akron,  Ohio,  44302
United States
 

Hematology Oncology Associates of Central New York, P.C. - Metro Center
Syracuse,  New York,  13217-6962
United States
 

All Saints Cancer Center at All Saints Healthcare
Racine,  Wisconsin,  53405
United States
 

Loyola University Medical Center
Maywood,  Illinois,  60153
United States
 

MD Anderson Cancer Center Orlando
Orlando,  Florida,  32806-2134
United States
 

Shands Cancer Center at the University of Florida - Gainesville
Gainesville,  Florida,  32610-0232
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 

Lehigh Valley Hospital
Allentown,  Pennsylvania,  18105
United States
 

Tom Baker Cancer Center - Calgary
Calgary,  Alberta,  T2N 4N2
Canada
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Medical College of Wisconsin Cancer Center
Milwaukee,  Wisconsin,  53226
United States
 

Cancer Treatment Center
Wooster,  Ohio,  44691
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068850;  RTOG-L-0117
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023673

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