Clinical trial · Interventional
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Oral Topotecan and Intravenous Carboplatin With G-CSF (Filgrastim) Support in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer
NCT00028925CI-TRIAL-00025062completedPhase 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.
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 |
| filgrastim | Biological | Filgrastim | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
| WBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen A
- description
- Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
- interventionNames
- Biological: filgrastim
- Drug: carboplatin
- Drug: topotecan hydrochloride
- Radiation: WBRT
- type
- EXPERIMENTAL
- label
- Regimen B
- description
- Patients receive topotecan and carboplatin as in regimen A. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung cancer * Previously untreated with chemotherapy * No mixed histology * Metastatic disease outside the chest * Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR * Cytologically proven malignant pleural effusion * Measurable disease * No untreated CNS metastases * CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST no greater than 5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * Bilirubin no greater than 1.5 times ULN OR * Direct bilirubin no greater than ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No uncontrolled angina pectoris * No congestive heart failure within the past 3 months unless ejection fraction is greater than 40% * No uncontrolled cardiac arrhythmias * No myocardial infarction within the past 3 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant infection * No hypersensitivity to E. coli-derived proteins * No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 5 years since prior chemotherapy for another malignancy * No prior nitrosoureas Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior thoracic radiotherapy * At least 1 day since prior palliative radiotherapy (except to chest) * No more than 3 fractions to chest for superior vena cava syndrome allowed * No concurrent radiotherapy (including thoracic radiotherapy) Surgery: * More than 3 weeks since prior major surgery
References
Publications (1)
- RESULTBryce AH, Mattar B, Hillman SL, Adjei AA, Kugler JW, Rowland K Jr, Wender DB, Soori G, Perez EA, Jett JR. Phase II trial of oral topotecan and intravenous carboplatin with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: A North Central Cancer Treatment Group Study. Am J Clin Oncol. 2010 Aug;33(4):353-7. doi: 10.1097/COC.0b013e3181b0c27f. PMID 19935387