Trial Outcomes & Findings for A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer (NCT NCT00584857)

Results Overview

Number of subjects alive at 3 years

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

3 years - median followup of 40.4 months

Results posted on

2017-01-27

Participant milestones
Measure	Paclitaxel/Carboplatin/Megesterol Acetate Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer

Baseline characteristics by cohort
Measure	Paclitaxel/Carboplatin/Megesterol Acetate n=30 Participants Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

Timeframe: 3 years - median followup of 40.4 months

Number of subjects alive at 3 years

Outcome measures
Measure	Paclitaxel/Carboplatin/Megesterol Acetate n=28 Participants Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
3-year Overall Survival	17 partipants

Timeframe: 3 years

Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria

Outcome measures
Measure	Paclitaxel/Carboplatin/Megesterol Acetate n=30 Participants Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
Toxicity	5 participants

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Paclitaxel/Carboplatin/Megesterol Acetate n=30 participants at risk Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
Vascular disorders deep vein thrombosis	10.0% 3/30 • Number of events 3
Surgical and medical procedures port fracture	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders pulmonary embolism	3.3% 1/30 • Number of events 1

Adverse event data not reported

UAB

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