Clinical trial · Interventional
Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
NCT00227565CI-TRIAL-00022886completedPhase 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, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage 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 |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pemetrexed + carboplatin + radiation
- description
- Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
- interventionNames
- Drug: carboplatin
- Drug: pemetrexed disodium
- Radiation: radiation
Primary outcomes (1)
- measure
- Proportion of confirmed-tumor response
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Previously untreated disease * No mixed histology * Extensive-stage disease * Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No symptomatic, untreated, or uncontrolled CNS metastases * CNS metastases previously treated with whole-brain radiotherapy allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR * Direct bilirubin normal * ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement) Renal * Creatinine clearance ≥ 45 mL/min Cardiovascular * No angina pectoris * No congestive heart failure within the past 3 months, unless ejection fraction \> 40% * No cardiac arrhythmia * No myocardial infarction within the past 3 months * No hypertension, including labile hypertension Pulmonary * No interstitial pneumonia * No extensive and symptomatic interstitial fibrosis of the lung Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of poor compliance with antihypertensive medication * Able to take folic acid, cyanocobalamin (vitamin B\_12) supplementation, or dexamethasone * No uncontrolled diabetes * No serious condition that would preclude study participation * No clinically significant infection * No significant traumatic injury * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if diagnosed \< 5 years prior to study entry * No seizure disorder * No other severe and/or uncontrolled medical condition PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent immunomodulating agents Chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy Radiotherapy * See Disease Characteristics * Prior palliative radiotherapy allowed * No prior palliative radiotherapy to the chest except for ≤ 3 fractions for superior vena cava syndrome * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery\* (i.e., laparotomy) or open biopsy * More than 2 weeks since prior minor surgery\* NOTE: \*Insertion of a vascular access device is not considered major or minor surgery Other * More than 4 weeks since prior investigational therapy * No concurrent Hypericum perforatum (St. John's wort) * No concurrent inducers or inhibitors of CYP3A4 * No concurrent medications that are metabolized by CYP3A4 * No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment * No other concurrent cytostatic or cytotoxic agents
References
Publications (2)
- RESULTChee CE, Jett JR, Bernath AM Jr, Foster NR, Nelson GD, Molina J, Nikcevich DA, Steen PD, Flynn PJ, Rowland KM Jr. Phase 2 trial of pemetrexed disodium and carboplatin in previously untreated extensive-stage small cell lung cancer, N0423. Cancer. 2010 May 15;116(10):2382-9. doi: 10.1002/cncr.24967. PMID 20209614
- RESULTJett JR, Bernath AM, Foster NR, et al.: Phase II trial of pemetrexed (P) and carboplatin (C) in previously untreated extensive stage disease small cell lung cancer (ED-SCLC): A NCCTG Study. [Abstract] J Clin Oncol 26 (Suppl 15): A-8066, 2008.