Trial Outcomes & Findings for Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer (NCT NCT00392769)
NCT ID: NCT00392769
Last Updated: 2012-09-06
Results Overview
Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.
COMPLETED
PHASE2
33 participants
Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.
2012-09-06
Participant Flow
Recruitment Period: October 10, 2006 to January 25, 2010. All recruitment done in a medical clinical setting.
Participant milestones
| Measure |
Cetuximab
400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Cetuximab
400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.
|
|---|---|
|
Overall Study
Clinical Deterioration
|
9
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab
n=33 Participants
400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.
|
|---|---|
|
Age Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.Population: There were ten inevaluable participants (completing less than 1 cycle).
Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.
Outcome measures
| Measure |
Cetuximab
n=23 Participants
400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.
|
|---|---|
|
Overall Disease Control Rate
|
17 percentage of participants
|
Adverse Events
Cetuximab
Serious adverse events
| Measure |
Cetuximab
n=33 participants at risk
400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33 • 3 years and 5 months
|
|
General disorders
Fatigue
|
39.4%
13/33 • 3 years and 5 months
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • 3 years and 5 months
|
|
General disorders
Headache
|
9.1%
3/33 • 3 years and 5 months
|
|
General disorders
Pain (all sites)
|
9.1%
3/33 • 3 years and 5 months
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • 3 years and 5 months
|
Other adverse events
| Measure |
Cetuximab
n=33 participants at risk
400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
72.7%
24/33 • 3 years and 5 months
|
|
General disorders
Fatigue
|
63.6%
21/33 • 3 years and 5 months
|
|
Gastrointestinal disorders
Constipation
|
24.2%
8/33 • 3 years and 5 months
|
|
General disorders
Headache
|
24.2%
8/33 • 3 years and 5 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
11/33 • 3 years and 5 months
|
|
General disorders
Pain (all sites)
|
24.2%
8/33 • 3 years and 5 months
|
|
Gastrointestinal disorders
Vomiting
|
24.2%
8/33 • 3 years and 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place