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Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous NSCLC

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ClinicalTrials.gov Identifier: NCT00769600
Recruitment Status : Terminated (Low accrual.)
First Posted : October 9, 2008
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Non Small Cell Lung Cancer
Interventions Drug: Itraconazole
Drug: Pemetrexed
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Hide Arm/Group Description

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: Itraconazole 200 mg once daily

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.

Pemetrexed

Period Title: Overall Study
Started 15 8
Completed 15 8
Not Completed 0 0
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed Total
Hide Arm/Group Description

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: Itraconazole 200 mg once daily

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.

Pemetrexed

Total of all reporting groups
Overall Number of Baseline Participants 15 8 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 8 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  80.0%
5
  62.5%
17
  73.9%
>=65 years
3
  20.0%
3
  37.5%
6
  26.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 8 participants 23 participants
60
(49 to 75)
59
(48 to 72)
59.5
(48 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 8 participants 23 participants
Female
7
  46.7%
5
  62.5%
12
  52.2%
Male
8
  53.3%
3
  37.5%
11
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 8 participants 23 participants
15 8 23
1.Primary Outcome
Title Overall Survival
Hide Description Median number of days alive
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Itraconazole plus pemetrexed
Pemetrexed alone
Overall Number of Participants Analyzed 15 8
Median (95% Confidence Interval)
Unit of Measure: days
971
(426 to 1135)
242 [1] 
(128 to NA)
[1]
the upper limit is not reached due to small sample size
2.Primary Outcome
Title Progression Free Survival as Measured by Number of Days Without Disease Progression
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Hide Arm/Group Description:

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: Itraconazole 200 mg once daily

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.
Overall Number of Participants Analyzed 15 8
Median (Full Range)
Unit of Measure: days
168
(82 to 364)
84
(21 to 210)
3.Primary Outcome
Title RECIST Response
Hide Description Number of participants with partial response (PR), stable disease (SD) and progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Hide Arm/Group Description:

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: Itraconazole 200 mg once daily

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.
Overall Number of Participants Analyzed 15 8
Measure Type: Count of Participants
Unit of Measure: Participants
PR
3
  20.0%
0
   0.0%
SD
8
  53.3%
5
  62.5%
PD
2
  13.3%
2
  25.0%
Inevaluable
2
  13.3%
1
  12.5%
4.Secondary Outcome
Title Tumor Blood Flow
Hide Description Tumor blood flow activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected to assess this outcome measure.
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Hide Arm/Group Description:

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: Itraconazole 200 mg once daily

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.

Pemetrexed

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Tumor Metabolic Activity
Hide Description Tumor metabolic activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected to assess this outcome measure.
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Hide Arm/Group Description:

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: Itraconazole 200 mg once daily

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.

Pemetrexed

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 30 days post last treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Hide Arm/Group Description

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: Itraconazole 200 mg once daily

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.

Pemetrexed

All-Cause Mortality
Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   6/15 (40.00%)   6/8 (75.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   2/15 (13.33%)   2/8 (25.00%) 
Blood and lymphatic system disorders     
Neutropenia   1/15 (6.67%)  0/8 (0.00%) 
Intratumoral Bleed   1/15 (6.67%)  0/8 (0.00%) 
Cardiac disorders     
Pulmonary Embolus   0/15 (0.00%)  1/8 (12.50%) 
General disorders     
Pain   0/15 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Itraconazole Open Label Added to Standard of Care Pemetrexed Single Agent Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   3/15 (20.00%)   2/8 (25.00%) 
Blood and lymphatic system disorders     
Lymphopenia   3/15 (20.00%)  2/8 (25.00%) 
Leukopenia   1/15 (6.67%)  0/8 (0.00%) 
General disorders     
Vertigo   1/15 (6.67%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   1/15 (6.67%)  1/8 (12.50%) 
Dyspnea   0/15 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Rudin, MD
Organization: MSKCCC
Phone: 646-888-4336
EMail: rudinc@mskcc.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00769600     History of Changes
Other Study ID Numbers: J0881JS
NA_00020074 ( Other Identifier: Johns Hopkins Institutional Review Board 2 )
First Submitted: October 8, 2008
First Posted: October 9, 2008
Results First Submitted: March 20, 2017
Results First Posted: February 1, 2019
Last Update Posted: February 1, 2019