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Trial record 1 of 4 for:    PGA niu
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(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma (PGA)

This study has been terminated.
(PI Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936974
First Posted: September 6, 2013
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
Western Regional Medical Center
Results First Submitted: September 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Ovarian Carcinoma
Fallopian Tube Carcinoma
Peritoneal Carcinoma
Interventions: Drug: Gemcitabine
Drug: Bevacizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Oxaliplatin

  Participant Flow
  Hide 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
Platinum, Gemcitabine and Bevacizumab

Platinum:

  1. Carboplatin* on day 1

    *If a patient is allergic to carboplatin, then give

  2. Cisplatin** on day 1

    **If a patient is allergic to cisplatin and carboplatin, then give

  3. Oxaliplatin on day 1

Gemcitabine on day 1 only

Bevacizumab on day 1

Gemcitabine

Bevacizumab

Carboplatin

Cisplatin

Oxaliplatin

Gemcitabine and Bevacizumab

Gemcitabine on days 1 and 8

Bevacizumab on day 1

Gemcitabine

Bevacizumab


Participant Flow:   Overall Study
    Platinum, Gemcitabine and Bevacizumab   Gemcitabine and Bevacizumab
STARTED   2   5 
COMPLETED   0   0 
NOT COMPLETED   2   5 
Physician Decision                2                5 



  Baseline Characteristics
  Hide 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
Platinum, Gemcitabine and Bevacizumab

Platinum:

  1. Carboplatin* on day 1

    *If a patient is allergic to carboplatin, then give

  2. Cisplatin** on day 1

    **If a patient is allergic to cisplatin and carboplatin, then give

  3. Oxaliplatin on day 1

Gemcitabine on day 1 only

Bevacizumab on day 1

Gemcitabine

Bevacizumab

Carboplatin

Cisplatin

Oxaliplatin

Gemcitabine and Bevacizumab

Gemcitabine on days 1 and 8

Bevacizumab on day 1

Gemcitabine

Bevacizumab

Total Total of all reporting groups

Baseline Measures
   Platinum, Gemcitabine and Bevacizumab   Gemcitabine and Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 


  Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: One Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  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: Jessica Coats, RN
Organization: CTCA
phone: 6232073899
e-mail: jessica.coats@ctca-hope.com



Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01936974     History of Changes
Other Study ID Numbers: 13-27
First Submitted: September 3, 2013
First Posted: September 6, 2013
Results First Submitted: September 27, 2017
Results First Posted: October 25, 2017
Last Update Posted: December 5, 2017