Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Carboplatin / Paclitaxel / Suramin Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)
Phase II trial to study the effectiveness of combining suramin, paclitaxel, and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer. 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.
PRIMARY OBJECTIVES:
I. Determine the minimum effective dose of suramin that will reduce resistance to
chemotherapy with paclitaxel and carboplatin in patients with stage IIIB or IV non-small
cell lung cancer (phase I). (Phase I closed to accrual 1/29/02).
II. Evaluate pharmacokinetic interactions of this drug combination in these patients (phase
I). (Phase I closed to accrual 1/29/02).
III. Determine the objective response rate in patients treated with this regimen (phase II
[chemotherapy-naive patients closed to accrual 9/1/03]).
IV. Determine the time to tumor progression, progression-free rate at 6 months, and 1-year
survival of patients treated with this regimen (phase II [chemotherapy-naive patients closed
to accrual 9/1/03]).
OUTLINE: Patients in phase II are stratified according to prior treatment (chemotherapy
naive [closed to accrual 9/1/03] vs chemotherapy refractory). Phase I (phase I closed to
accrual 1/29/02):
Patients receive suramin IV over 30 minutes on days 1 and 2. Patients also receive
paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of suramin until the target dose is
determined. The target dose is defined as the dose at which at least 5 of 6 patients achieve
optimal plasma concentrations of suramin and no more than 1 of 6 patients exceed optimal
level. Doses of paclitaxel are adjusted until the maximum tolerated dose in combination with
suramin and paclitaxel is determined.
Phase II (chemotherapy-naive patients closed to accrual 9/1/03): Patients receive the target
dose of suramin IV over 30 minutes on days 1 and 2. Patients also receive paclitaxel IV over
3 hours and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence
of disease progression or unacceptable toxicity. Patients are followed every 3-6 weeks.
PROJECTED ACCRUAL: Approximately 82 patients (18 for phase I [phase I closed to accrual
1/29/02] and 64 for phase II [chemotherapy-naive patients closed to accrual 9/1/03]) will be
accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01664754 -
Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT02451930 -
A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC
|
Phase 1 | |
Withdrawn |
NCT02106559 -
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
|
N/A | |
Completed |
NCT02364609 -
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
|
Phase 1 | |
Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT01935336 -
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|
Phase 2 | |
Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01839955 -
Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Terminated |
NCT01193868 -
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
|
Phase 2 | |
Completed |
NCT00986674 -
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00963807 -
Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC
|
Phase 2 | |
Completed |
NCT00087412 -
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00085280 -
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00052338 -
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT02879994 -
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT03305380 -
Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth
|
||
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT02858869 -
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
|
Phase 1 | |
Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT02566421 -
Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery
|
N/A |