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Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study has been terminated.
(lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903630
First Posted: May 18, 2009
Last Update Posted: January 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.
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
Results First Submitted: April 22, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions: Drug: Lenalidomide
Drug: liposomal doxorubicin

  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
Fifteen subjects were enrolled in this combined phase l/ll study - 11 subjects in phase l and 4 in phase ll. Six of the subjects enrolled in phase 1 were treated at the maximum tolerated dose (MTD) and their data was included in the phase 2 analysis as allowed by the protocol.

Reporting Groups
  Description
Phase 1 - Dose Level 1 liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Phase 1 - Dose Level 2 liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Phase 2 - Dose Level 1 liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days

Participant Flow for 2 periods

Period 1:   Phase l
    Phase 1 - Dose Level 1   Phase 1 - Dose Level 2   Phase 2 - Dose Level 1
STARTED   6   5   0 
COMPLETED   6   5   0 
NOT COMPLETED   0   0   0 

Period 2:   Phase 2
    Phase 1 - Dose Level 1   Phase 1 - Dose Level 2   Phase 2 - Dose Level 1
STARTED   6   0   4 
COMPLETED   6   0   3 [1] 
NOT COMPLETED   0   0   1 
Adverse Event                0                0                1 
[1] One participant was removed from the study after 2 weeks of treatment due to skin toxicity.



  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.
One of the 4 subjects enrolled in the Phase 2 portion of the study was removed from the study 2 weeks after the start of treatment due to a skin rash leaving 9 evaluable subjects for the Phase 2 analysis. All 15 subjects from both the Phase 1 and Phase 2 portions of the trial were included in the Serious and Non-Serious Adverse Events analysis.

Reporting Groups
  Description
Phase 1 - Dose Level 1 No text entered.
Phase 1 - Dose Level 2 No text entered.
Phase 2 No text entered.
Total Total of all reporting groups

Baseline Measures
   Phase 1 - Dose Level 1   Phase 1 - Dose Level 2   Phase 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   5   4   15 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  50.0%      3  60.0%      3  75.0%      9  60.0% 
>=65 years      3  50.0%      2  40.0%      1  25.0%      6  40.0% 
Gender 
[Units: Participants]
Count of Participants
       
Female      6 100.0%      5 100.0%      4 100.0%      15 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   6   5   4   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer   [ Time Frame: 1 cycle (28 days) ]

2.  Primary:   Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)   [ Time Frame: within 5 weeks of starting treatment ]

3.  Primary:   Phase 2 - Number of Subjects Achieving a Partial or Complete Response   [ Time Frame: 3 months after starting treatment ]

4.  Secondary:   Phase 2 - Number of Subjects Who Are Progression-Free and Alive   [ Time Frame: 3 months after starting treatment ]

5.  Secondary:   Phase 2 - Number of Subjects Who Are Progression-Free and Alive   [ Time Frame: 6 months after starting treatment ]


  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
No text entered.


  More Information
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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:  
Name/Title: Dr. Levi Downs, Jr
Organization: University of Minnesota, Dept. of OBGYN
phone: 612-626-3111
e-mail: downs008@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00903630     History of Changes
Other Study ID Numbers: 2008LS047
0805M32463 ( Other Identifier: IRB, University of Minnesota )
WCC #50 ( Other Identifier: Women's Cancer Center, University of Minnesota )
RV-OVAR-PI-0447 ( Other Identifier: Celgene Corporation )
First Submitted: May 15, 2009
First Posted: May 18, 2009
Results First Submitted: April 22, 2015
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017