Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Nab-Paclitaxel and Carboplatin With Concurrent Radiation Therapy for Unresectable Stage III Non-Small-Cell Lung Cancer (NSCLC)
Verified date | May 2014 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Nab-paclitaxel (paclitaxel
albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to
radiation therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may
kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving
nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works
in treating patients with stage III non-small-cell lung cancer that cannot be removed by
surgery.
Status | Terminated |
Enrollment | 13 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria for Phase I and Phase II Patients: - Patients must voluntarily sign and date an informed consent before the initiation of any study procedures - Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion - Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC - Patients must have at least one site of unidirectionally measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) criteria - Patients must be = 3 weeks from a formal exploratory thoracotomy - Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry - Patients must be = 18 years of age - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Women of childbearing potential must have a negative baseline serum pregnancy or a negative urine pregnancy test within 7 days prior to Week 1, Day 1 and must not be breast feeding. - Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy. - Patients must have adequate hepatic, renal, lung and bone marrow function as defined below: - Absolute neutrophil count (ANC) =1,500/mm3 - Hemoglobin = 9.0 gm/dL - Serum Creatinine =1.5mg/dl - Platelets > 100,000/mm3 - Total bilirubin = upper limit of normal - AST and ALT < 2.5 X upper limit of normal - Alkaline phosphatase < 2.5 X upper limit of normal - Calculated CrCl > 45 ml/min (via Cockroft-Gault formula) - Forced expiratory volume in 1 second (FEV 1) > 800 ml Exclusion Criteria for Phase I and Phase II Patients: - Known hypersensitivity to carboplatin or nab-paclitaxel - Peripheral neuropathy Grade = 2 - Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC - Previous chemotherapy or radiation therapy to the chest - Any concomitant malignancy or brain metastasis - Any uncontrolled, clinically significant medical or psychiatric disorder - Pregnant or nursing women - A greater than or equal to 10% weight loss over the past 3 months |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga | Tennessee |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee |
United States | Purchase Cancer Group - Paducah | Paducah | Kentucky |
United States | Oregon Health Sciences University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression | Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens. | On receipt of tumor tissue blocks | No |
Primary | Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I) | The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks. | 7 weeks | Yes |
Primary | Progression-free Survival (Phase II) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions | On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years) | No |
Secondary | Progression-free Survival (Phase I) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions | On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years) | No |
Secondary | Overall Survival (Phase I) | Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details). | On-study date to date of death from any cause (assessed up to 2 years) | No |
Secondary | Response (Phase I) | Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | On-treatment date to date of progressive disease (assessed up to 2 years) | No |
Secondary | Number of Patients With Each Worst Grade Toxicity (Phase I) | Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. | On-study date to 30 days following final dose of study drug | Yes |
Secondary | Overall Survival (Phase II) | Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival | Time Frame: date on study to date of death from any cause or last known date alive | No |
Secondary | Number of Patients With Each Worst Grade Toxicity (Phase II) | The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death | at 16 weeks | Yes |
Secondary | Response (Phase II) | Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | On-treatment date to date of progressive disease (assessed up to 2 years) | No |
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
|