Clinical trial · Interventional
Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer
Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer
NCT00454324CI-TRIAL-00028564NRRterminatedPhase 2Results postedClinicalTrials.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)
This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung cancer to examine overall response rate, time to progressive disease, survival time, and assessment of toxicity profile for Carboplatin and Abraxane.
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
- interventionNames
- Drug: Carboplatin
- Drug: Abraxane
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
- interventionNames
- Drug: Carboplatin
- Drug: Abraxane
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytological diagnosis of extensive stage small-cell lung cancer (ES-SCLC),\* including malignant pleural effusion 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 3. No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC 4. Measurable disease as defined by the RECIST criteria 5. Adequate organ function as defined by the protocol 6. Female patients of child bearing potential (CBP) must agree to use of reliable method of birth control during and for 3 months following treatment 7. Patients must sign informed consent document 8. Patients must be ≥ 18 years of age 9. Patients with brain metastases that have been adequately treated and are determined to be controlled by the attending physician are eligible 10. Patients who have had prior malignancies are eligible if they are ≥ 5 years from diagnosis free of disease or the attending physician believes the patient's prognosis is best defined by the ES-SCLC (if questions concerning this eligibility criteria arise, please contact the principal investigator) (\*)ES-SCLC defined as metastases outside the chest, pulmonary metastases, or contralateral metastases (supraclavicular or hilar) nodes that could not be included with a reasonable single radiation port. Patients with malignant pleural effusions are considered extensive stage. Exclusion Criteria: 1. Received treatment within the last 30 days with a drug that has not received Food and Drug Administration (FDA) approval for any indication at the time of study entry 2. Pregnancy or breast feeding 3. Serious active infection that would require a prolonged course (4-6 weeks) of antibiotics or would compromise the safety of the patient or compromise the patient's ability to complete the study 4. Symptomatic brain metastases 5. Grade ≥ 2 neuropathy using NCI CTCAE version 3.0 criteria 6. Previous anaphylactic reaction to carboplatin, paclitaxel, and docetaxel 7. Severe or uncontrolled cardiac disease, defined as uncontrolled or unstable angina, myocardial infarction in the last month, uncontrolled congestive heart failure (≥ 3 admissions for congestive heart failure in the 3 months prior to diagnosis)
References
Publications (1)
- DERIVEDGrilley-Olson JE, Keedy VL, Sandler A, Moore DT, Socinski MA, Stinchcombe TE. A randomized phase II study of carboplatin with weekly or every-3-week nanoparticle albumin-bound paclitaxel (abraxane) in patients with extensive-stage small cell lung cancer. Oncologist. 2015 Feb;20(2):105-6. doi: 10.1634/theoncologist.2014-0327. Epub 2015 Jan 23. PMID 25616430