Completed
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
50
Participants Needed
1
Research Sites
N/A
Total Duration
2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973; Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.
CONDITIONS
Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer
You may qualify if you...
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer of the following histologies: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, No mixed small/non-small cell carcinoma with predominant small cell component.
Unresectable stage IIIA/B disease confined to thorax including:
Microscopic disease involvement following attempted surgery and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4).
Surgically treated stage I/II disease with histologic or cytologic proof of relapse and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4).
T3, N0 tumor extending directly to the chest wall considered resectable and not eligible.
No stage IIIB disease with pleural effusion visible on chest x-ray unless related to a previous thoracotomy.
No typical carcinoid or mesothelioma.
Measurable disease preferred but not required.
PRIOR/CONCURRENT THERAPY:
No prior chemotherapy or thoracic radiotherapy.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic:
AGC greater than 2,000.
Platelets greater than 100,000.
Hepatic: Bilirubin no greater than 1.5 mg/dL.
Renal: Creatinine no greater than 1.5 mg/dL.
Cardiovascular:
No symptomatic heart disease including: Less than fully compensated congestive cardiac failure, Significant arrhythmias e.g.: Greater than first-degree heart block, Uncontrolled and symptomatic atrial dysrhythmia except sinus, bradycardia or sustained ventricular tachycardia, Myocardial infarction within 3 months.
Pulmonary: No major uncontrolled active infection (unless due to obstructed bronchus).
OTHER:
No major active psychiatric problem requiring hospitalization or psychotropic medication such as phenothiazines.
No prior second malignancy within 5 years except: nonmelanomatous skin cancer, In situ carcinoma of the cervix.
No pregnant or nursing women.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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