We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ixabepilone to Treat Cervical Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924066
First Posted: June 18, 2009
Last Update Posted: June 9, 2014
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.
Information provided by (Responsible Party):
Antonio Fojo, M.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: March 13, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
  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
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
  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
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 
Overall Participants Analyzed 
[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
  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:  
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
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: March 13, 2014
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014