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Trial record 10 of 526 for:    "Primary Peritoneal Carcinoma"

Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, 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: NCT00582205
Recruitment Status : Terminated (Study completed per investigator.)
First Posted : December 28, 2007
Results First Posted : May 18, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Uterine Cancer
Intervention Drug: Paclitaxel, Cisplatin IP
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paclitaxel, Cisplatin IP
Hide Arm/Group Description

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Period Title: Overall Study
Started 21
Completed 11
Not Completed 10
Arm/Group Title Paclitaxel, Cisplatin IP
Hide Arm/Group Description

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  81.0%
>=65 years
4
  19.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
61
(29 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
21
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
 100.0%
1.Primary Outcome
Title Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel, Cisplatin IP
Hide Arm/Group Description:

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
7
  41.2%
2.Secondary Outcome
Title Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel, Cisplatin IP
Hide Arm/Group Description:

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
7
  41.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel, Cisplatin IP
Hide Arm/Group Description

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

All-Cause Mortality
Paclitaxel, Cisplatin IP
Affected / at Risk (%)
Total   0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel, Cisplatin IP
Affected / at Risk (%) # Events
Total   1/21 (4.76%)    
Gastrointestinal disorders   
small bowel obstruction   1/21 (4.76%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Paclitaxel, Cisplatin IP
Affected / at Risk (%) # Events
Total   6/21 (28.57%)    
Blood and lymphatic system disorders   
Neutropenia  [1]  6/21 (28.57%)  6
Indicates events were collected by systematic assessment
[1]
Resulting in dose delays
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Joan Walker
Organization: University of Oklahoma
Phone: 405-271-8707
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00582205     History of Changes
Other Study ID Numbers: WalkerIP
First Submitted: December 19, 2007
First Posted: December 28, 2007
Results First Submitted: April 12, 2017
Results First Posted: May 18, 2017
Last Update Posted: July 2, 2017