Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973; Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.
Detailed Description
This is a Phase II study of paclitaxel administered as a 96-hour (4 day) continuous infusion with a bolus of cisplatin followed by chest radiotherapy for previously untreated patients with stage III n...
Eligibility Criteria
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.
Key Trial Info
Start Date :
March 1 1996
Trial Type :
INTERVENTIONAL
End Date :
June 1 2000
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00001499
Start Date
March 1 1996
End Date
June 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892