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Abraxane and Alimta in Advanced Solid Tumors

This study has been terminated.
(Practice patterns with pemetrexed have evolved.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470548
First Posted: May 7, 2007
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Celgene
Eli Lilly and Company
Information provided by (Responsible Party):
University of California, Davis
Results First Submitted: January 17, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: Abraxane
Drug: Alimta

  Participant Flow
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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
Phase I: Dose Level 1 Pemetrexed 500 mg/m2 plus Abraxane 180 mg/m2
Phase I: Dose Level 2 Pemetrexed 500 mg/m2 plus Abraxane 220 mg/m2
Phase I: Dose Level 3 Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
Phase II Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2

Participant Flow:   Overall Study
    Phase I: Dose Level 1   Phase I: Dose Level 2   Phase I: Dose Level 3   Phase II
STARTED   3   3   6   37 
COMPLETED   3   3   6   37 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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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
Phase I: Abraxane and Pemetrexed A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
Phase II: Abraxane and Pemetrexed Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
Total Total of all reporting groups

Baseline Measures
   Phase I: Abraxane and Pemetrexed   Phase II: Abraxane and Pemetrexed   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   37   49 
Age 
[Units: Years]
Median (Full Range)
 70 
 (51 to 76) 
 63 
 (45 to 77) 
 63 
 (45 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  41.7%      14  37.8%      19  38.8% 
Male      7  58.3%      23  62.2%      30  61.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   12   37   49 


  Outcome Measures
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1.  Primary:   Number of Participants With Dose Limiting Toxicities   [ Time Frame: Up to21 days ]

2.  Primary:   Number of Patients With Toxicities   [ Time Frame: Up to 1 year ]

3.  Secondary:   Duration of Overall Survival   [ Time Frame: Up to 2 years ]

4.  Secondary:   Number of Participants With Complete Response   [ Time Frame: Up to 2 years ]

5.  Secondary:   Number of Participants With Stable Disease   [ Time Frame: Up to 2 years ]

6.  Secondary:   Number of Participants With Partial Response   [ Time Frame: Up to 2 years ]

7.  Secondary:   Number of Participants With Disease Control   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The phase II portion accrued 37 patients before early closure due to increasing the first-line pemetrexed/platinum doublet use in non-squamous NSCLC.


  More Information
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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 0294
e-mail: pkaujla@ucdavis.edu


Publications of Results:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00470548     History of Changes
Other Study ID Numbers: UCDCC#185
H3E-US-I017 ( Other Grant/Funding Number: Eli Lilly )
ABX027 ( Other Grant/Funding Number: Celgene )
First Submitted: May 3, 2007
First Posted: May 7, 2007
Results First Submitted: January 17, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017