This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Bortezomib and Pemetrexed Disodium in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00389805
First received: October 18, 2006
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: January 20, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: bortezomib
Drug: pemetrexed disodium
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry
Other: immunoenzyme technique
Other: immunohistochemistry staining method

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m3) on days 1, 4, 8, and 11 every 21 days
Arm B Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m2) on days 1 and 8 every 21 days

Participant Flow for 2 periods

Period 1:   Phase I
    Arm A   Arm B
STARTED   15   12 
COMPLETED   15   12 
NOT COMPLETED   0   0 

Period 2:   Phase II
    Arm A   Arm B
STARTED   0 [1]   0 [1] 
COMPLETED   0   0 
NOT COMPLETED   0   0 
[1] The Phase II study was not conducted.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
Arm B Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   12   27 
Age 
[Units: Years]
Median (Full Range)
 62 
 (30 to 79) 
 59 
 (45 to 80) 
 60 
 (39 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  40.0%      8  66.7%      14  51.9% 
Male      9  60.0%      4  33.3%      13  48.1% 
Region of Enrollment 
[Units: Participants]
     
United States   15   12   27 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Experiencing a Dose-limiting Toxicity (Phase I)   [ Time Frame: Up to 36 months ]

2.  Primary:   Number of Participants Who Experience Adverse Events (Phase I)   [ Time Frame: Throughout the entire study (up to 36 months). ]

3.  Primary:   Number of Patients With Grade ≥ 3 Toxicity (Phase I)   [ Time Frame: First cycle of treatment (3 weeks) ]

4.  Primary:   Number of Patients Who Responded to Study Treatment (Phase II)   [ Time Frame: From start of treatment until disease progression/recurrence. ]

5.  Secondary:   Number of Patients With Toxicity by NCI CTC v3.0 (Phase I)   [ Time Frame: Up to 36 months ]

6.  Secondary:   Maximum Tolerated Dose of Bortezomib in Combination With Pemetrexel (Phase I)   [ Time Frame: Up to 36 months ]

7.  Secondary:   Treatment Efficacy as Measured by RECIST (Phase I)   [ Time Frame: Up to 36 months ]

8.  Secondary:   Number of Participants With Toxicities (Phase II)   [ Time Frame: Up to 36 months ]

9.  Secondary:   Analysis of Molecular Determinants in Tumor Samples (Phase II)   [ Time Frame: Up to 36 months ]

10.  Secondary:   Importance of Folate-associated Gene Expression and Response or Outcome (Phase II)   [ Time Frame: Up to 36 months ]

11.  Secondary:   Effect of Bortezomib on Over Expression of NF-kB, BCL-2, and BCL-xL (Phase II)   [ Time Frame: Up to 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Analyst
Organization: University of California, Davis
phone: 916-734-8053
e-mail: nlogihara@ucdavis.edu


Publications of Results:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00389805     History of Changes
Other Study ID Numbers: UCDCC#158
H3E-US-X038 ( Other Identifier: Eli Lilly )
Study First Received: October 18, 2006
Results First Received: January 20, 2017
Last Updated: April 7, 2017