Trial Outcomes & Findings for A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus (NCT NCT00584909)

Results Overview

Number of months of survival with no evidence of disease

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

4 years - Median follow up time of 45.3 months

Results posted on

2017-01-27

Participant milestones
Measure	Paclitaxel + Carboplatin Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	Paclitaxel + Carboplatin Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
Overall Study Adverse Event	4

A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus

Baseline characteristics by cohort
Measure	Paclitaxel + Carboplatin n=13 Participants Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

Timeframe: 4 years - Median follow up time of 45.3 months

Number of months of survival with no evidence of disease

Outcome measures
Measure	Paclitaxel + Carboplatin n=9 Participants Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
Disease-free Survival	50.5 months Interval 35.5 to 55.9

Timeframe: 4 years

Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version

Outcome measures
Measure	Paclitaxel + Carboplatin n=9 Participants Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
Toxicity	9 participants

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Paclitaxel + Carboplatin n=9 participants at risk Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
Immune system disorders Neutropenia	66.7% 6/9 • Number of events 12
Nervous system disorders Neuropathy	22.2% 2/9 • Number of events 2
Blood and lymphatic system disorders Thrombocytopenia	22.2% 2/9 • Number of events 2
Gastrointestinal disorders Gastrointestinal	11.1% 1/9 • Number of events 1
Renal and urinary disorders Urinary tract infection	11.1% 1/9 • Number of events 1
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Number of events 1

UAB

Phone: 205-934-4986