Clinical trial · Interventional
Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
NCT00984542CI-TRIAL-00014001completedPhase 2Results postedClinicalTrials.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, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory 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 |
|---|---|---|---|
| bendamustine hydrochloride | Drug | Bendamustine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine
- interventionNames
- Drug: bendamustine hydrochloride
Primary outcomes (1)
- measure
- Time to Progression
- timeFrame
- On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)
- description
- Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Secondary outcomes (4)
- measure
- Number of Patients With Each Worst-grade Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Relapsed or refractory disease after 1-2 prior chemotherapy regimens * Measurable disease * ECOG - Eastern Cooperative Oncology Group performance status 0-2 * ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin normal * AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST) * Creatinine clearance \> 40 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study therapy * No known hypersensitivity to bendamustine * No other malignancy for which the patient has been treated within the past year except for nonmelanoma skin cancer or carcinoma in situ of the cervix * No cardiac disease, including any of the following: * Unstable angina pectoris * Life-threatening cardiac arrhythmia * Symptomatic congestive heart failure * No uncontrolled infection * No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
References
Publications (0)
Data not yet available
No reference posted for this study.