Clinical trial · Interventional
Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy
Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
NCT00084487CI-TRIAL-00014678terminatedPhase 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)
Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.
Conditions
Conditions (3)
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 |
| Limited Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| becatecarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (becatecarin)
- description
- Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: becatecarin
Primary outcomes (3)
- measure
- Objective Response Rate Estimated as the Proportion of Responders
- timeFrame
- Up to 4 years
- description
- Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. An exact binomial 95% confidence interval will be calculated for this proportion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of small cell lung cancer (SCLC) * Limited or extensive stage * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Sensitive\* relapsed disease after only 1 prior chemotherapy regimen * Brain metastasis allowed provided the following criteria are met: * Stable brain disease * Not receiving irradiation * No steroid requirement to control symptoms * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * At least 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present) * Bilirubin ≤ 1.5 mg/dL * Creatinine \< 2.0 mg/dL * Creatinine clearance ≥ 60 mL/min * No New York Heart Association class III or IV heart disease * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active or ongoing infection * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * See Disease Characteristics * See Disease Characteristics * See Disease Characteristics * Prior radiotherapy allowed * No other concurrent investigational agents * No other concurrent therapies for SCLC * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.