Clinical trial · Interventional
Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Sorafenib in Conjunction With Chemotherapy and as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Extreme toxicity
Summary
Brief summary (as posted)
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide 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 |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib, Cisplatin, and Etoposide
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- Drug: sorafenib tosylate
Primary outcomes (1)
- measure
- Progression-free Survival(PFS)
- timeFrame
- 1-year
- description
- PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Secondary outcomes (3)
- measure
- Median Overall Survival
- timeFrame
- 1-year
- description
- Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of extensive-stage small cell lung cancer * No untreated brain metastases * No active symptoms related to brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 9.0 g/dL * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement) * Creatinine ≤ 1.5 times ULN * INR \< 1.5 or PT/PTT normal * No history of cardiac disease, including any of the following: * NYHA class III-IV congestive heart failure * Unstable angina (i.e., anginal symptoms at rest) * Onset of angina within the past 3 months * Myocardial infarction within the past 6 months * No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management * No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks * No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No known HIV infection or chronic hepatitis B or C infection * No active clinically serious infection \> CTCAE grade 2 * No serious non-healing wound, ulcer, or bone fracture * No evidence or history of bleeding diathesis or coagulopathy * No significant traumatic injury within the past 4 weeks * No known or suspected allergy to sorafenib tosylate or to any other drug given during the study * No condition that would impair the patient's ability to swallow whole pills * No known malabsorption problem * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * Male patients must use effective contraception during and for ≥ 3 months after completion of sorafenib tosylate PRIOR CONCURRENT THERAPY: * Prior radiotherapy to the brain allowed * No prior chemotherapy * More than 4 weeks since prior major surgery or open biopsy * No concurrent Hypericum perforatum (St. John's wort) or rifampin * Concurrent anti-coagulation treatment, such as warfarin or heparin, allowed
References
Publications (0)
Data not yet available