Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
NCT00041314CI-TRIAL-00067196completedPhase 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 carboplatin, gemcitabine, and exisulind in treating patients who have 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| exisulind | Drug | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR * Stage IV * Prior brain metastases are allowed provided the following are true: * Patient completed radiotherapy and/or surgery at least 3 weeks prior to study * Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI * Patient is neurologically improved or stable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 g/L * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 mg/dL * SGOT no greater than 1.5 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No prior uncontrolled cardiovascular disease * No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No serious active infection * No dementia or active psychoses * No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * At least 1 month since prior investigational agents * More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen) * No concurrent sulindac or COX-2 inhibitors
References
Publications (1)
- RESULTMasters GA, Li S, Dowlati A, Madajewicz S, Langer C, Schiller J, Johnson D. A phase II trial of carboplatin and gemcitabine with exisulind (IND #65,056) in patients with advanced non-small cell lung cancer: an Eastern Cooperative Oncology Group study (E1501). J Thorac Oncol. 2006 Sep;1(7):673-8. PMID 17409935