Lung Cancer Clinical Trial
Official title:
Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
yet known whether cisplatin combined with irinotecan is more effective than cisplatin
combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with
either irinotecan or etoposide in treating patients who have extensive-stage small cell lung
cancer.
OBJECTIVES:
- Compare the survival of patients with extensive stage small cell lung cancer treated
with cisplatin and irinotecan vs cisplatin and etoposide.
- Compare the objective response rate and progression-free survival of patients treated
with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic
effects in these patients.
- Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of
patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number
of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit
of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs
more than 5%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin
IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
- Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV
over 30-60 minutes on day 1. Courses repeat every 3 weeks.
Treatment in both arms continues for 4 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this
study within 4 years.
;
| 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 |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| 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 |
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 |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
| 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
|