Clinical trial · Interventional
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC
NCT00001450CI-TRIAL-00001225completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.