Clinical trial · Interventional
Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
NCT00087048CI-TRIAL-00021455terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (4)
- measure
- Safety and toxic effects
- measure
- Recurrence-free survival
- measure
- Time to response and tumor response
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer (SCLC) * Recurrent extensive stage disease * No mixed histology * Measurable disease * At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI * Sensitive disease * Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy) * Eligible for high-dose chemotherapy * No symptomatic brain metastases affecting performance status PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Hematocrit \> 35% (without transfusion) Hepatic * Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal\* * Alkaline phosphatase ≤ 2 times normal\* * Bilirubin ≤ 2.0 mg/dL * Albumin \> 2.5 g/dL * Hepatitis B surface antigen negative * No significant hepatic disease Note: \*≤ 5 times upper limit of normal if liver metastases are present Renal * Creatinine clearance ≥ 40 mL/min Cardiovascular * No history of cardiac arrhythmias * No congestive heart failure * No ischemic heart disease * No stroke or other embolic disease requiring daily treatment that would preclude study participation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No known seizure disorder * No active infection requiring systemic therapy within the past 2 weeks * No known hypersensitivity to topotecan hydrochloride * No medical or psychiatric condition that would preclude study participation * No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy * No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC * No prior topotecan hydrochloride Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 2 months since prior investigational agent * No other concurrent investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.