Non-small Cell Lung Cancer Metastatic Clinical Trial
— NA_00067809Official title:
A Randomized Phase II Study of SUBATM-itraconazole With Cisplatin/Gemcitabine in Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer.
Verified date | September 2018 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Response rates.
Changes in tumor blood flow.
Status | Terminated |
Enrollment | 3 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Stage IV squamous cell lung cancer, with no prior systemic chemotherapy. - Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 6 months have elapsed from completion of that treatment. - Patients whose tumors contain mixed non-small cell histologies are eligible if squamous carcinoma is the predominant histology. Mixed tumors with small cell anaplastic elements are not eligible. - Patient must have measurable disease per RECIST 1.1 (defined in section 9.1.2). - Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Radiation therapy must have been completed greater than or equal to 2 weeks prior to enroll in this study. - Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of itraconazole or SUBATM-itraconazole in combination with gemcitabine/cisplatin in patients under 18 years of age, such patients are excluded from this study. Squamous cell lung cancer is exceedingly rare in children. - Life expectancy of at least 12 weeks. - Eastern Cooperative Oncology Group performance status 0 - 1. - Patients must have adequate organ and marrow function. - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Prior treatment with gemcitabine, cisplatin (except in the adjuvant setting), itraconazole or SUBATM-itraconazole. - Uncontrolled brain metastases. Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole, SUBATM-itraconazole, gemcitabine, cisplatin or other agents used in the study. - Itraconazole is a strong CYP3A4 inhibitor and may increase plasma concentrations of drugs metabolized by this pathway. Co-administration of cisapride, midazolam, pimozide, quinidine, lovastatin, simvastatin, triazolam, dofetilide, or levacetylmethadol (levomethadyl) with SUBATM-itraconazole or itraconazole is contraindicated. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant women are excluded from this study because itraconazole is Class C agent and both gemcitabine and cisplatin are Class D agents, with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SUBATM-itraconazole and gemcitabine/cisplatin, breastfeeding should be discontinued if the mother is to be treated on this protocol. - HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SUBATM-itraconazole, gemcitabine, or cisplatin with these essential mediations. - Medical contra-indication to MRI (e.g. gadolinium allergy, or severe claustrophobia). |
Country | Name | City | State |
---|---|---|---|
United States | Bayview Medical Center at Johns Hopkins | Baltimore | Maryland |
United States | Johns Hopkins University, SKCCC | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rates | Per response evaluation criteria in solid tumors criteria | 6 weeks | |
Primary | Tumor Blood Flow. | To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole. | 6 weeks. | |
Secondary | Median Time to Progression | To determine the median time to progression and median duration of survival of patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole. | 2 years. | |
Secondary | Adverse Effects | To characterize the adverse effects of cisplatin and gemcitabine with or without SUBATM-itraconazole in this patient population. | 2 years. | |
Secondary | Itraconazole Exposure Parameters | To correlate itraconazole exposure parameters with median time to progression and median survival in this patient population. | 2 years. | |
Secondary | Tumor Necrosis | To assess changes in tumor necrosis in response to cisplatin and gemcitabine with or without SUBATM-itraconazole. | 2 years. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01523340 -
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
|
||
Recruiting |
NCT03956641 -
Evolution of the Physical Condition in Treated Cancer Patients
|
N/A | |
Active, not recruiting |
NCT02035683 -
PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy
|
N/A | |
Completed |
NCT01848613 -
Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC
|
Phase 4 | |
Suspended |
NCT01320501 -
Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 4 | |
Terminated |
NCT01471964 -
Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT06127940 -
K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation
|
Phase 1 | |
Terminated |
NCT04069936 -
Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC
|
Phase 2 | |
Terminated |
NCT03445000 -
ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03386929 -
Survival Prolongation by Rationale Innovative Genomics
|
Phase 1/Phase 2 | |
Recruiting |
NCT02922764 -
A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer
|
Phase 1 | |
Terminated |
NCT01574300 -
Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
|
||
Active, not recruiting |
NCT04646824 -
Almonertinib With Chemotherapy in mEGFR NSCLC
|
Phase 2 | |
Completed |
NCT01966003 -
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 3 | |
Recruiting |
NCT03656094 -
Chemotherapy With Pembrolizumab Continuation After Progression to PD-1/L1 Inhibitors
|
Phase 2 | |
Terminated |
NCT01348126 -
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03469960 -
Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr
|
Phase 3 | |
Recruiting |
NCT05919264 -
FOG-001 in Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT04793815 -
Lung Cancer Cryo-Activation as a Novel Approach to Augment Immunotherapy Efficacy (CRYOVATE)
|
N/A | |
Terminated |
NCT01380795 -
Feasibility of the Research for Mutation of K-ras and EGFR in CTCs From Metastatic Non Small Cells Bronchial Carcinomas
|
Early Phase 1 |