Clinical trial · Interventional
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide
- 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 in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have 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 |
|---|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Biological | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PET (Topotecan/Etoposide/Cisplatin/G-CSF)
- description
- Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
- interventionNames
- Biological: G-CSF
- Drug: Cisplatin
- Drug: Etoposide
- Drug: Topotecan
- type
- EXPERIMENTAL
- label
- PIE (Irinotecan/Cisplatin/Etoposide)
- description
- Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
- interventionNames
- Drug: Cisplatin
- Drug: Etoposide
- Drug: Irinotecan
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization * Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Disease-free for \>=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix * Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) \>=4000/mm3 and platelets \>=100,000/mm3; bilirubin \<= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) \<=2.5 x upper limit of normal if no demonstrable liver metastases or \<=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance \>=30 using the formulas in the protocol * Age 18 and older * Strongly advised to use an accepted and effective method of contraception * Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy * Those receiving erythropoietin could continue to receive it EXCLUSION CRITERIA: * Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases * Prior chemotherapy for this disease * Pregnant or lactating
References
Publications (0)
Data not yet available