A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (Itraconazole)
This study has been terminated.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
First received: October 8, 2008
Last updated: March 18, 2013
Last verified: March 2013
To evaluate the 3-month event-free survival of the combination of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.
To determine the objective response rate of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.
Recurrent Non Small Cell Lung Cancer
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer
Primary Outcome Measures:
- Cycles will be repeated until disease progression, unacceptable toxicity, or until the patient or the investigator requests therapy discontinuation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Active Comparator: Itraconazole Open Label added to standard of care pemetrexed
All subjects will receive standard dose pemetrexed (500 mg/m2) on day 1 of each 21-day cycle, via intravenous infusion over 10 minutes. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21) or pemetrexed alone. Cycles will be repeated until disease progression, unacceptable toxicity, or until the patient or the investigator requests therapy discontinuation.
Itraconazole 200 mg once daily
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Patients may not be receiving any other investigational agents.
- Patients who have received prior pemetrexed chemotherapy.
- Patients with 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 and pemetrexed or other agents used in the study.
- Itraconazole is a strong CYP3A4 inhibitor and may increase plasma concentrations of drugs metabolized by this pathway. Coadministration of cisapride, midazolam, pimozide, quinidine, lovastatin, simvastatin, triazolam, dofetilide, or levacetylmethadol (levomethadyl) with itraconazole is contraindicated. Patients who take any of these medications and who are not able to change to an alternative medication will be excluded. Lists including medications and substances known or with the potential to interact with the CYP3A4 isoenzymes are provided in Section 7.1.
- 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 and pemetrexed are Class C and D agents, respectively, 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 itraconazole and pemetrexed, breastfeeding should be discontinued if the mother is treated with itraconazole or pemetrexed. These potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with itraconazole or pemetrexed. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00769600
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
|Baltimore, Maryland, United States, 21231 |
|Singapore General Hospital
|Jalan Tan Tock Seng, Singapore, 308433 |
Sidney Kimmel Comprehensive Cancer Center
||Sidney Kimmel Comprehensive Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 8, 2008
||March 18, 2013
||United States: Institutional Review Board
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Recurrent Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2016
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors