Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung
- 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 III trial to compare different 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- oral topotecan plus cisplatin IV
- description
- oral topotecan once daily on days 1-5 and cisplatin IV on day 5
- interventionNames
- Drug: cisplatin
- Drug: topotecan hydrochloride
- type
- EXPERIMENTAL
- label
- Cisplatin IV plus etoposide IV
- description
- Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
- interventionNames
- Drug: cisplatin
- Drug: etoposide
Primary outcomes (0)
[]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 carcinoma (SCLC) * No prior chemotherapy for SCLC OR * No chemotherapy within 5 years of diagnosis of SCLC * Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing * No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI * Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 9.0 g/dL * WBC at least 3,500/mm3 * Platelet count at least 100,000/mm3 * Neutrophil count at least 1,500/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No pre-existing renal impairment that would preclude cisplatin use Gastrointestinal: * No clinical evidence of any gastrointestinal (GI) conditions including: * Removal of a portion of the stomach * History of recent obstruction of the GI tract * GI autonomic neuropathy * Ulcerative colitis * Crohn's disease * Malabsorption syndrome * Treatment with cyclosporine that would alter absorption or GI motility * No other conditions that would preclude absorption of oral topotecan Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study * No active infection * No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer * No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance * No prior allergic reactions to compounds chemically related to study drugs * No pre-existing hearing impairment that would preclude cisplatin use * No overall medical condition for which study drugs would be inappropriate PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy for SCLC Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy for SCLC Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy for SCLC Radiotherapy: * See Disease Characteristics * At least 24 hours since prior radiotherapy with no expected bone marrow suppression * Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium) * No concurrent radiotherapy for SCLC * No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator Surgery: * At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient) Other: * More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs * No other concurrent investigational therapy for SCLC * No concurrent cyclosporine * No concurrent drugs that would preclude absorption of oral topotecan
References
Publications (0)
Data not yet available