Lung Cancer Clinical Trial
Official title:
A Phase I Study of NX 211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2, and 3 Every 3 Weeks in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one chemotherapy drug may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in
treating patients who have advanced or metastatic solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of
lurtotecan liposome and cisplatin in patients with advanced solid tumors. II. Determine the
toxicity profile, dose-limiting toxic effects, and the pharmacokinetics of this treatment
regimen in this patient population. III. Determine any correlation between toxicity profile
and pharmacokinetics of this treatment regimen in these patients. IV. Determine the objective
tumor response to this treatment regimen in patients with measurable disease (previously
untreated solid tumors) entered at the recommended phase II dose.
OUTLINE: This is an open-label, multicenter, dose-escalation study of lurtotecan liposome.
Patients receive cisplatin IV over 1 hour followed by lurtotecan liposome IV over 30 minutes
on days 1-3. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity. Once the total dose of cisplatin is reached, patients receive
lurtotecan liposome alone. Patients achieving complete response (CR) continue therapy for 2
courses after documentation of confirmed CR. Patients achieving partial response (PR)
continue therapy until progression or for 2 courses after documentation of stable PR.
Patients with stable disease continue therapy for a maximum of 6 courses. Cohorts of 3-6
patients receive escalating doses of lurtotecan liposome until the maximum tolerated dose
(MTD) is reached. The MTD is defined as the dose at which at least 2 of 6 patients experience
dose-limiting toxicity. Once the MTD is determined, up to 10 patients with previously
untreated solid tumors are treated at the recommended phase II dose (1 dose below the MTD).
Patients are followed at 4 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15
months.
;
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 |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
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 | |
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
|