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Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00057863
First received: April 7, 2003
Last updated: October 16, 2015
Last verified: December 2012
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Interventions: Drug: Paclitaxel
Drug: Oxaliplatin

  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 35 patients were enrolled in the study from April 2003 until August 2008.

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
Treatment (Paclitaxel, Oxaliplatin)

Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Paclitaxel: Given IV

Oxaliplatin: Given IV


Participant Flow:   Overall Study
    Treatment (Paclitaxel, Oxaliplatin)
STARTED   35 
COMPLETED   32 
NOT COMPLETED   3 
Death                1 
Withdrawal by Subject                2 



  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 (Paclitaxel, Oxaliplatin)

Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Paclitaxel: Given IV

Oxaliplatin: Given IV


Baseline Measures
   Treatment (Paclitaxel, Oxaliplatin) 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Median (Full Range)
 56 
 (27 to 78) 
Gender 
[Units: Participants]
 
Female   32 
Male   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   12 
Hispanic   9 
Black   8 
Asian   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Objective Response Rate (CR+PR)   [ Time Frame: Up to 7 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: From first treatment day until objective or symptomatic progression or death, assessed up to 7 years ]

3.  Secondary:   Overall Survival   [ Time Frame: From first treatment day until death, assessed up to 7 years ]

4.  Secondary:   Toxicities, Assessed and Graded According to CTCAE Version 3.0   [ Time Frame: Up to 7 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057863     History of Changes
Other Study ID Numbers: NCI-2012-03004
NCI-2012-03004 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-5840
0902-492 ( Other Identifier: Montefiore Medical Center - Moses Campus )
5840 ( Other Identifier: CTEP )
N01CM62204 ( US NIH Grant/Contract Award Number )
P30CA013330 ( US NIH Grant/Contract Award Number )
Study First Received: April 7, 2003
Results First Received: October 16, 2015
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration