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A Randomized Phase II Study of SUBATM-itraconazole With Cisplatin/Gemcitabine in Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer

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Trial Information

A Randomized Phase II Study of SUBATM-itraconazole With Cisplatin/Gemcitabine in Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer.


To determine the objective response rates of cisplatin and gemcitabine with or without
SUBATM-itraconazole in patients with chemotherapy-naïve metastatic squamous non-small cell
lung cancer.

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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rates

Outcome Description:

To determine the objective response rates of cisplatin and gemcitabine with or without SUBATM-itraconazole in patients with chemotherapy-naïve metastatic squamous non-small cell lung cancer.

Outcome Time Frame:

6 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

J1230

NCT ID:

NCT01752023

Start Date:

December 2012

Completion Date:

June 2014

Related Keywords:

  • Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Johns Hopkins University, SKCCCBaltimore, Maryland  21287