Clinical trial · Interventional
Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer
NCT00004126CI-TRIAL-00009403completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin in treating patients who have recurrent or advanced non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Paclitaxel 175 mg/m2 : administered by 1-hour constant rate IV infusion through a pump on day 1 of each cycle. Oxaliplatin 130 mg/m2 : On Day 1 of each 21-day treatment cycle, patients receive oxaliplatin diluted in 250-500 mL Dextrose 5% in Water infused intravenously over 2 hours.
- interventionNames
- Drug: oxaliplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB with pleural effusion OR Stage IV OR Recurrent disease Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT less than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min BUN less than 1.5 times normal Cardiovascular: No symptomatic congestive heart failure No unstable angina or myocardial infarction within the past 6 months No evidence of heart block greater than first degree, bundle branch block, or ventricular or supraventricular arrhythmia Other: No allergy to platinum compounds or antiemetics appropriate for study No other uncontrolled illness No active or ongoing infection No evidence of peripheral neuropathy by physical exam or history Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced NSCLC At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy for HIV positive patients
References
Publications (1)
- RESULTWinegarden JD, Mauer AM, Otterson GA, Rudin CM, Villalona-Calero MA, Lanzotti VJ, Szeto L, Kasza K, Hoffman PC, Vokes EE; University of Chicago Phase II Network; Ohio State University. A phase II study of oxaliplatin and paclitaxel in patients with advanced non-small-cell lung cancer. Ann Oncol. 2004 Jun;15(6):915-20. doi: 10.1093/annonc/mdh215. PMID 15151948