Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

This study has been terminated.
(Study was terminated due to lack of available funding.)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00331422
First received: May 30, 2006
Last updated: November 6, 2012
Last verified: November 2012
Results First Received: November 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions: Drug: carboplatin
Drug: paclitaxel
Procedure: cytoreductive surgery

  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
Patients Who Received Treatment Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).

Participant Flow:   Overall Study
    Patients Who Received Treatment  
STARTED     7 [1]
COMPLETED     2 [2]
NOT COMPLETED     5  
Did not receive entire study regimen                 5  
[1] Patients who met study criteria and received at least one dose of study drug.
[2] Completed all 6 courses of chemotherapy and had surgery to remove all tumor lesions.



  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
Patients Who Received Treatment Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).

Baseline Measures
    Patients Who Received Treatment  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     4  
Age  
[units: Years]
Median ( Full Range )
  67  
  ( 57 to 80 )  
Gender  
[units: participants]
 
Female     7  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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1.  Primary:   Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy   [ Time Frame: Week 18 (After 4 cycles of chemotherapy) ]

2.  Secondary:   Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Week 16 (4 weeks after 4th course) ]

3.  Secondary:   Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration   [ Time Frame: From Baseline to up to 12 weeks (4 courses of therapy) ]

4.  Secondary:   Change in Drug Resistance After Neoadjuvant Chemotherapy   [ Time Frame: Day 1 to Time to Surgery (Approximately Week 18) ]

5.  Secondary:   Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density   [ Time Frame: Week 18 (At surgery) ]

6.  Secondary:   Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy   [ Time Frame: Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment) ]


  Serious Adverse Events


  Other Adverse Events


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


Limitations and Caveats
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
1 of the 2 evaluable patients was switched from Paclitaxel to Taxotere during the course of her treatment due to toxicity (adverse effects), but since it remains a platinum-based chemotherapy she is included in the evaluable group.  


Results Point of Contact:  
Name/Title: Melissa Geller, MD
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-3111
e-mail: gelle005@umn.edu


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00331422     History of Changes
Other Study ID Numbers: 2004LS070, UMN-0409M64006, UMN- WCC-40
Study First Received: May 30, 2006
Results First Received: November 23, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration