Ixabepilone to Treat Cervical Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Fojo, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00924066
First received: June 17, 2009
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: March 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cervical Carcinoma
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Carcinoma, Non-SquamousType
Intervention: Drug: Ixempra (Ixabepilone (BMS-247550) )

  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
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Reporting Groups
  Description
Squamous and Nonsquamous Participants

Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.

Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.

All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle.


Participant Flow:   Overall Study
    Squamous and Nonsquamous Participants  
STARTED     41  
COMPLETED     41  
NOT COMPLETED     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.
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Reporting Groups
  Description
Squamous and Nonsquamous Participants

Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.

Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.

All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle.


Baseline Measures
    Squamous and Nonsquamous Participants  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Mean ± Standard Deviation
  46.79  ± 9.17  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     40  
>=65 years     1  
Gender  
[units: participants]
 
Female     41  
Male     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     34  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     3  
Not Hispanic or Latino     37  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     41  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tumor Response (PR + CR) Per RECIST   [ Time Frame: Every 6 weeks, up to 15 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 61 months ]


  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
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  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: Antonio Fojo, M.D.
Organization: National Cancer Institute
phone: 301-496-2631
e-mail: fojot@mail.nih.gov


Publications:

Responsible Party: Antonio Fojo, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00924066     History of Changes
Obsolete Identifiers: NCT00798928
Other Study ID Numbers: 090037, 09-C-0037
Study First Received: June 17, 2009
Results First Received: March 13, 2014
Last Updated: May 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration