Trial Outcomes & Findings for Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix (NCT NCT00626561)
NCT ID: NCT00626561
Last Updated: 2014-07-07
Results Overview
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
TERMINATED
PHASE2
4 participants
Baseline to 6 Months, or until disease progression.
2014-07-07
Participant Flow
Recruitment Period: February 18, 2008 to November 04, 2010. All recruitment done at University of Texas (UT) MD Anderson Cancer Center.
Study was terminated early due to low accrual. One participant enrolled of four withdrew before being treatment.
Participant milestones
| Measure |
Bevacizumab + Paclitaxel
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Bevacizumab + Paclitaxel
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
2
|
Baseline Characteristics
Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix
Baseline characteristics by cohort
| Measure |
Bevacizumab + Paclitaxel
n=4 Participants
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.
|
|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 Months, or until disease progression.Population: Interim analysis was to be done after 10 patients enrolled, accrual not met. Study halted early.
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab + Paclitaxel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bevacizumab + Paclitaxel
n=3 participants at risk
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Adverse event data obtained every cycle (approximately every 4 weeks) until 30 days post treatment. Overall study period 2 years, May 2008 to May 2010.
One participant of four was enrolled but not treated therefore excluded from adverse event reporting.
|
|
General disorders
Pain
|
66.7%
2/3 • Adverse event data obtained every cycle (approximately every 4 weeks) until 30 days post treatment. Overall study period 2 years, May 2008 to May 2010.
One participant of four was enrolled but not treated therefore excluded from adverse event reporting.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse event data obtained every cycle (approximately every 4 weeks) until 30 days post treatment. Overall study period 2 years, May 2008 to May 2010.
One participant of four was enrolled but not treated therefore excluded from adverse event reporting.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Adverse event data obtained every cycle (approximately every 4 weeks) until 30 days post treatment. Overall study period 2 years, May 2008 to May 2010.
One participant of four was enrolled but not treated therefore excluded from adverse event reporting.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse event data obtained every cycle (approximately every 4 weeks) until 30 days post treatment. Overall study period 2 years, May 2008 to May 2010.
One participant of four was enrolled but not treated therefore excluded from adverse event reporting.
|
Additional Information
Michael M. Frumovitz, MD / Professor, Gynecologic Oncology
University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place