Overview
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC
Status:
Completed
Completed
Trial end date:
2000-06-01
2000-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Paclitaxel
Criteria
DISEASE CHARACTERISTICS:Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma,
Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant
small cell component.
Eligible Stages Include:
Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence
that is histologically or cytologically proven.
CNS Metastases Allowed Provided:
Radiotherapy completed prior to entry.
No requirement for concurrent steroids.
No carcinomatous meningitis.
No epidural metastases.
Measurable disease not required.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy: No prior chemotherapy for lung cancer.
Endocrine Therapy: Not specified.
Radiotherapy: No prior chest irradiation for lung cancer.
Surgery: Prior surgery allowed.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance Status: ECOG 0-2.
Hematopoietic:
Absolute granulocyte count greater than 2,000.
Platelet count greater than 100,000.
Hepatic: Bilirubin no greater than 1.5 mg/dL.
Renal: Creatinine no greater than 1.5 mg/dL.
Cardiovascular:
No CHF unless fully compensated.
No second- or third-degree heart block.
No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia.
No sustained ventricular tachycardia.
No MI within 3 months.
OTHER:
No uncontrolled infection unless due to an obstructed bronchus.
No major psychiatric problems requiring hospitalization.
No psychotropic medications such as phenothiazines.
No contraindication to transfusion, if required.
No second malignancy within 5 years except: Nonmelanomatous skin cancer.
In situ cervical cancer.
No pregnant or nursing women.
Effective contraception required of fertile patients.