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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Morris, M.D., Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00227721
First received: September 26, 2005
Last updated: February 16, 2016
Last verified: February 2016
Results First Received: November 18, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Median (Full Range)
  57.5  
  (41 to 80)  
Gender  
[units: participants]
 
Female     29  
Male     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.   Safety Issue:   No


  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, M.D., Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00227721     History of Changes
Other Study ID Numbers: CDR0000445432
P30CA022453 ( US NIH Grant/Contract Award Number )
WSU-C-2713
Study First Received: September 26, 2005
Results First Received: November 18, 2014
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration