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Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182767
First received: September 15, 2005
Last updated: February 11, 2016
Last verified: February 2014
Results First Received: June 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Female Reproductive Cancer
Recurrent Breast Cancer
Recurrent Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Breast Cancer
Stage IV Ovarian Epithelial Cancer
Interventions: Drug: ixabepilone
Drug: pegylated liposomal doxorubicin hydrochloride

  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
A total of 45 patients were enrolled and treated between January 2006 and May 2011

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
Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1

Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.

ixabepilone: Given IV

pegylated liposomal doxorubicin hydrochloride: Given IV

Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2

Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.

ixabepilone: Given IV

pegylated liposomal doxorubicin hydrochloride: Given IV

Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3

Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.

ixabepilone: Given IV

pegylated liposomal doxorubicin hydrochloride: Given IV

Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4

Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.

ixabepilone: Given IV

pegylated liposomal doxorubicin hydrochloride: Given IV

Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5

Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.

ixabepilone: Given IV

pegylated liposomal doxorubicin hydrochloride: Given IV


Participant Flow:   Overall Study
    Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1   Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2   Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3   Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4   Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5
STARTED   6   6   6   3   24 
COMPLETED   6   6   6   3   24 
NOT COMPLETED   0   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
Treatment (Ixabepilone and Doxorubicin)

Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.

ixabepilone: Given IV

pegylated liposomal doxorubicin hydrochloride: Given IV


Baseline Measures
   Treatment (Ixabepilone and Doxorubicin) 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Years]
Median (Full Range)
 59 
 (34 to 82) 
Gender 
[Units: Participants]
 
Female   45 
Male   0 


  Outcome Measures
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1.  Primary:   Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I)   [ Time Frame: 28 days ]

2.  Primary:   Maximum Tolerated Dose   [ Time Frame: Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD). ]

3.  Secondary:   Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)   [ Time Frame: Up to 2 years ]

4.  Secondary:   Progression-free Survival   [ Time Frame: The time from start of treatment to time of progression or death, assessed 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Escobar-Peralta, Program Manager
Organization: Montefiore Medical Center
phone: 718-379-6866
e-mail: lescobar@montefiore.org


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182767     History of Changes
Other Study ID Numbers: NCI-2009-00140
NCI-2009-00140 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
0504007857 ( Other Identifier: Montefiore Medical Center - Moses Campus )
7229 ( Other Identifier: CTEP )
N01CM62204 ( US NIH Grant/Contract Award Number )
P30CA013330 ( US NIH Grant/Contract Award Number )
Study First Received: September 15, 2005
Results First Received: June 17, 2015
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration