Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma

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.
 
ClinicalTrials.gov Identifier: NCT00183794
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 25, 2013
Last Update Posted : May 22, 2014
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Eli Lilly and Company
Information provided by (Responsible Party):
University of Southern California

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Carcinoma
Peritoneal Neoplasms
Intervention Drug: Docetaxel and Gemcitabine
Enrollment 20
Recruitment Details Participants were recruited from the USC+LAC Women's Hospital and the USC/Norris Cancer Hospital between December 2002 and April 2008.
Pre-assignment Details  
Arm/Group Title Gemcitabine and Docetaxel
Hide Arm/Group Description Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Gemcitabine and Docetaxel
Hide Arm/Group Description Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Between 43 and 75 years Number Analyzed 20 participants
59
(43 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
13
  65.0%
Not Hispanic or Latino
7
  35.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
  20.0%
More than one race
0
   0.0%
Unknown or Not Reported
12
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Tumor Response Type: CR, PR, SD or PD
Hide Description Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.
Time Frame 6 months after enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.
Arm/Group Title Gemcitabine and Docetaxel
Hide Arm/Group Description:
Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
CR 1
PR 4
SD 9
PD 6
2.Secondary Outcome
Title Median Time to Progression (Months)
Hide Description Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)
Time Frame 6 months after enrollment of last patient
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive the first course of treatment are included in the summary of PFS.
Arm/Group Title Gemcitabine and Docetaxel
Hide Arm/Group Description:
Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: Months
3
(1 to 23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine and Docetaxel
Hide Arm/Group Description Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
All-Cause Mortality
Gemcitabine and Docetaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine and Docetaxel
Affected / at Risk (%) # Events
Total   12/20 (60.00%)    
Blood and lymphatic system disorders   
Anemia   1/20 (5.00%)  2
Febrile Neutropenia *  2/20 (10.00%)  2
Gastrointestinal disorders   
Vomiting *  1/20 (5.00%)  1
General disorders   
Fatigue *  1/20 (5.00%)  1
Infections and infestations   
Wound Infection *  1/20 (5.00%)  1
Investigations   
Alkaline Phosphatase Increased   1/20 (5.00%)  1
Neutrophil Count Decreased   11/20 (55.00%)  29
Platelet Count Decreased   1/20 (5.00%)  2
White Blood Cell Decreased   5/20 (25.00%)  12
Metabolism and nutrition disorders   
Hyperglycemia   1/20 (5.00%)  2
Hypoalbuminemia   1/20 (5.00%)  1
Hypophosphatemia   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine and Docetaxel
Affected / at Risk (%) # Events
Total   13/20 (65.00%)    
Blood and lymphatic system disorders   
Anemia   1/20 (5.00%)  13
Cardiac disorders   
Palpitations *  1/20 (5.00%)  1
Eye disorders   
Watering Eyes *  1/20 (5.00%)  1
Gastrointestinal disorders   
Nausea   4/20 (20.00%)  4
Vomiting *  2/20 (10.00%)  2
Ascites   1/20 (5.00%)  2
Diarrhea *  3/20 (15.00%)  3
Constipation *  3/20 (15.00%)  4
Abdominal Pain *  2/20 (10.00%)  3
Mucosits Oral *  2/20 (10.00%)  4
General disorders   
Fatigue *  7/20 (35.00%)  12
Pin *  1/20 (5.00%)  1
Localized Edema *  4/20 (20.00%)  6
Fever *  3/20 (15.00%)  5
Chills *  3/20 (15.00%)  4
Injury, poisoning and procedural complications   
Bruising *  2/20 (10.00%)  2
Investigations   
Creatinine Increased   1/20 (5.00%)  1
Neutrophil Count Decreased   1/20 (5.00%)  12
White Blood Cell Decreased   10/20 (50.00%)  14
Platelet Count Decreased   7/20 (35.00%)  13
Blood Bilirubin Increased   1/20 (5.00%)  1
Alkaline Phosphatase   3/20 (15.00%)  3
Weight Gain *  1/20 (5.00%)  2
Aspartate Aminotrasferase Increased   3/20 (15.00%)  5
Alanine Aminotransferase Increased   3/20 (15.00%)  5
Metabolism and nutrition disorders   
Hypocalcemia   1/20 (5.00%)  1
Hypernatremia   1/20 (5.00%)  1
Hyperglycemia   3/20 (15.00%)  5
Hypophosphatemia   1/20 (5.00%)  1
Hypoalbuminemia   1/20 (5.00%)  2
Hyponatremia   2/20 (10.00%)  2
Anorexia *  2/20 (10.00%)  3
Musculoskeletal and connective tissue disorders   
Back Pain *  1/20 (5.00%)  2
Nervous system disorders   
Peripheral Motor Neuropathy   2/20 (10.00%)  2
Peripheral Sensory Neuropathy   6/20 (30.00%)  9
Dizziness *  3/20 (15.00%)  4
Renal and urinary disorders   
Urinary Tract Pain *  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  3/20 (15.00%)  5
Cough *  2/20 (10.00%)  3
Epistaxis *  1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia *  5/20 (25.00%)  5
Rash/Acneiform *  4/20 (20.00%)  7
Skin Disorder - Other (specify: skin tear) *  1/20 (5.00%)  1
Nail Discoloration *  3/20 (15.00%)  3
Purpura *  1/20 (5.00%)  1
Vascular disorders   
Hot Flashes *  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Agustin Garcia, MD
Organization: USC/Norris Cancer Comprehensive Cancer Center
Phone: 323-865-3900
EMail: aagarcia@usc.edu
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183794     History of Changes
Other Study ID Numbers: 5GYN-02-2
First Submitted: September 9, 2005
First Posted: September 16, 2005
Results First Submitted: October 6, 2012
Results First Posted: January 25, 2013
Last Update Posted: May 22, 2014