Lung Cancer Clinical Trial
Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
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.
Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 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 de-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 highest dose at which no more than 1 patient experiences dose-limiting toxicity.
Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (up to 27 for phase I [closed to accrual as of 10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable stage 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 lung cancer within the past 2 years
Ineligible for currently open Radiation Therapy Oncology Group (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
Aspartate aminotransferase (AST) less than 2 times upper limit of normal
Renal:
Creatinine no greater than 2.0 mg/dL
Pulmonary:
Forced expiratory volume (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
Completed 3D plan with total lung V20
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
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There are 38 Locations for this study
Mobile Alabama, 36652, United States
Phoenix Arizona, 85013, United States
Burbank California, 91505, United States
Mission Hills California, 91346, United States
Sacramento California, 95817, United States
Panama City Florida, 32401, United States
Gainesville Georgia, 30501, United States
Alton Illinois, 62002, United States
Elk Grove Village Illinois, 60007, United States
Mount Vernon Illinois, 62864, United States
Hammond Indiana, 46320, United States
Muncie Indiana, 47303, United States
Pascagoula Mississippi, 39581, United States
Cape Girardeau Missouri, 63701, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65807, United States
Brick New Jersey, 08724, United States
Toms River New Jersey, 08755, United States
Vineland New Jersey, 08360, United States
East Syracuse New York, 13057, United States
High Point North Carolina, 27261, United States
Akron Ohio, 44309, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Wooster Ohio, 44691, United States
Grants Pass Oregon, 97527, United States
Medford Oregon, 97504, United States
Medford Oregon, 97504, United States
Philadelphia Pennsylvania, 19141, United States
Rapid City South Dakota, 57701, United States
Galveston Texas, 77555, United States
Lubbock Texas, 79410, United States
Wheeling West Virginia, 26003, United States
La Crosse Wisconsin, 54601, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Calgary Alberta, T2N 4, Canada
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