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Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227721
First Posted: September 28, 2005
Last Update Posted: March 27, 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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Morris, Barbara Ann Karmanos Cancer Institute
Results First Submitted: November 18, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Peritoneal Cavity Cancer
Interventions: Drug: Docetaxel
Drug: Gemcitabine 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
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
Docetaxel & Gemcitabine Hydrochloride

Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle

Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days

Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days


Participant Flow:   Overall Study
    Docetaxel & Gemcitabine Hydrochloride
STARTED   30 
COMPLETED   29 
NOT COMPLETED   1 
On study, but never treated.                1 



  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
Docetaxel & Gemcitabine Hydrochloride

Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle

Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days

Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days


Baseline Measures
   Docetaxel & Gemcitabine Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Median (Full Range)
 57.5 
 (41 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      29 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   29 


  Outcome Measures

1.  Primary:   Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.   [ Time Frame: Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first). ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Every two cycles ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Small sample size


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Morris, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
phone: 313-576-9436
e-mail: rmorris@med.wayne.edu



Responsible Party: Robert Morris, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00227721     History of Changes
Other Study ID Numbers: CDR0000445432
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-C-2713
First Submitted: September 26, 2005
First Posted: September 28, 2005
Results First Submitted: November 18, 2014
Results First Posted: February 9, 2015
Last Update Posted: March 27, 2017