A Phase 2 interventional study of paclitaxel and cisplatin in Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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. In addition, the plasma levels of paclitaxel will be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells from as many patients as possible will be determined. This will allow further study of the relationship between in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and patients' response to therapy.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 58 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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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.
This study is completed, as verified in Jul 1999. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
National Cancer Institute (NCI)