A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (Itraconazole)
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|ClinicalTrials.gov Identifier: NCT00769600|
Recruitment Status : Terminated (Low accrual.)
First Posted : October 9, 2008
Last Update Posted : October 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non Small Cell Lung Cancer||Drug: Itraconazole Drug: Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
Active Comparator: Itraconazole Open Label added to standard of care pemetrexed
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. 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).
Itraconazole 200 mg once daily
Active Comparator: Single agent pemetrexed
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.
- Cycles will be repeated until disease progression, unacceptable toxicity, or until the patient or the investigator requests therapy discontinuation. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769600
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Singapore General Hospital|
|Jalan Tan Tock Seng, Singapore, 308433|