Clinical trial · Interventional
Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer
NCT00017251CI-TRIAL-00009098completedPhase 1ClinicalTrials.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 use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen 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 |
|---|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oblimersen sodium | Biological | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oblimersen sodium, carboplatin, etoposide)
- description
- Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
- interventionNames
- Biological: oblimersen sodium
- Drug: carboplatin
- Drug: etoposide
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
- timeFrame
- Up to 3 years
- description
- Data will be summarized separately for each dose level, by severity, and type of toxicity.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed extensive stage small cell lungcancer * No active CNS disease * CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 2 months * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * PT and PTT no greater than 1.5 times ULN * Creatinine normal * Creatinine clearance at least 60 mL/min * 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 prior allergic reactions to compounds of similar chemical or biologic composition to study agents * No other uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * See Disease Characteristics * At least 1 week since prior CNS radiotherapy and recovered * No prior radiotherapy to more than 25% of skeleton * No other prior anticancer therapy * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent anticoagulation therapy * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.