Clinical trial · Interventional
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
NCT00006004CI-TRIAL-00067195completedPhase 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. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes: * Squamous cell * Adenocarcinoma * Large cell anaplastic * Bronchioalveolar * Non-small cell carcinoma not otherwise specified * No small cell anaplastic elements allowed * Must have: * Recurrent disease after prior radiotherapy or surgery OR * Stage IV disease with distant metastases OR * Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray * Bidimensionally measurable or evaluable disease * Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No uncontrolled high blood pressure, unstable angina, or congestive heart failure * No myocardial infarction within the past 6 months * No serious ventricular arrhythmias requiring medication Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other active malignancies requiring ongoing treatment * No uncontrolled serious active infections * No suspected hypersensitivity to agents that utilize Cremophor * No evidence of neuropathy grade 2 or greater by history or physical examination PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for non-small cell lung cancer Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology * Recovered from prior radiotherapy * No concurrent radiotherapy except for whole brain radiation for developing brain metastases Surgery: * See Disease Characteristics
References
Publications (3)
- RESULTLanger C, Li S, Schiller J, Tester W, Rapoport BL, Johnson DH; Eastern Cooperative Oncology Group. Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007 Feb 1;25(4):418-23. doi: 10.1200/JCO.2005.04.9452. PMID 17264337
- RESULTTester WJ, Stephenson P, Langer CJ, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin or gemcitabine/cisplatin in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 22 (Suppl 14): A-7055, 630s, 2004.
- RESULTLanger CJ, Stephenson P, Schiller J, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin vs cisplatin/gemcitabine in performance status (PS) 2 patients with treatment-naive advanced NSCLC. [Abstract] Lung Cancer 41 (Suppl 2): A-O52, S18, 2003.