Lung Cancer Clinical Trial
Official title:
Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
formulation and carboplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. Giving more than one drug
(combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle
formulation given together with carboplatin works in treating patients with stage IIIB, stage
IV, or recurrent non-small cell lung cancer.
OBJECTIVES:
Primary
- To determine the response rate, in terms of overall response rate (complete response and
partial response), of paclitaxel albumin-stabilized nanoparticle formulation and
carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who
are ineligible for treatment with bevacizumab.
Secondary
- To evaluate safety of this regimen in these patients.
- To describe the overall survival of these patients.
- To describe progression-free survival of these patients.
Tertiary Objectives
- To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers
including serum SPARC levels, methylation of SPARC in primary tumor samples and serum,
Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression
profiles.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to
6 courses in the absence of disease progression or unacceptable toxicity.
Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for
correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND
SPARC by immunohistochemistry, and serum miRNA expression profiling.
After completion of study treatment, patients are followed periodically.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
| Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
| Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
| Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
| Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
| Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|