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Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT01188876
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Marcela G. del Carmen, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Interventions: Drug: carboplatin
Drug: pralatrexate
Drug: Folic Acid
Drug: Vitamin B12 Injection

  Participant Flow

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
Carboplatin/Pralatrexate

carboplatin: Given intravenously on Day 1 of each 28-day cycle

pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle.


Participant Flow:   Overall Study
    Carboplatin/Pralatrexate
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  Baseline Characteristics

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
Carboplatin/Pralatrexate

carboplatin: Given intravenously on Day 1 of each 28-day cycle

pralatrexate: Given intravenously on Day 1 and Day 15 of each 28-day cycle.


Baseline Measures
   Carboplatin/Pralatrexate 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Median (Full Range)
 59 
 (39 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      50 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      49  98.0% 
Unknown or Not Reported      1   2.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   48 
Black or African American   1 
Other   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   50 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
 
    34  68.0% 
    16  32.0% 
[1]

Eastern Cooperative Oncology Group (ECOG) score

  • 0: Asymptomatic (Fully active, able to carry on all pre-disease activities without restriction)
  • 1: Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
Primary Site 
[Units: Participants]
Count of Participants
 
Ovary      34  68.0% 
Fallopian Tube      6  12.0% 
Peritoneal      5  10.0% 
Other      5  10.0% 
Histology Subtype 
[Units: Participants]
Count of Participants
 
Serous      30  60.0% 
Endometrioid      6  12.0% 
Transitional Cell      1   2.0% 
Carcinosarcoma      3   6.0% 
Other      10  20.0% 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 1 year ]

2.  Primary:   Best Overall Response   [ Time Frame: 1 Year ]

3.  Secondary:   Overall Survival   [ Time Frame: 6, 12, 18, and 24 months ]

4.  Secondary:   Progression Free Survival   [ Time Frame: 3 months, 6 months ]

5.  Secondary:   Treatment Related Adverse Events   [ Time Frame: 1 Year ]

6.  Secondary:   Maximum Concentration of Drug in Plasma (Cmax)   [ Time Frame: Day 1 and Day 15 ]

7.  Secondary:   Area Under the Plasma Drug Concentration-Time Curve (AUC)   [ Time Frame: Day 1 and Day 15 ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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


Results Point of Contact:  
Name/Title: Marcela del Carmen, MD, MPH
Organization: Massachusetts General Hospital
phone: 617-724-4800
e-mail: MDELCARMEN@mgh.harvard.edu



Responsible Party: Marcela G. del Carmen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01188876     History of Changes
Other Study ID Numbers: 10-113
First Submitted: August 24, 2010
First Posted: August 26, 2010
Results First Submitted: November 22, 2017
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018