Trial Outcomes & Findings for (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma (NCT NCT01936974)
NCT ID: NCT01936974
Last Updated: 2018-02-20
Results Overview
Evaluate progression-free survival between the two regimens.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
One Year
Results posted on
2018-02-20
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
5
|
Baseline Characteristics
(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: One YearPopulation: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.
Evaluate progression-free survival between the two regimens.
Outcome measures
Outcome data not reported
Adverse Events
Platinum, Gemcitabine and Bevacizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gemcitabine and Bevacizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place