Trial Outcomes & Findings for Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer (NCT NCT00470067)
NCT ID: NCT00470067
Last Updated: 2014-08-22
Results Overview
Response Rate
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Every 28 days
Results posted on
2014-08-22
Participant Flow
Participant milestones
| Measure |
Doxorubicin and Carboplatin
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Doxorubicin and Carboplatin
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease Progression
|
6
|
Baseline Characteristics
Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Doxorubicin and Carboplatin
n=9 Participants
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 28 daysPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Response Rate
Outcome measures
Outcome data not reported
Adverse Events
Doxorubicin and Carboplatin
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin and Carboplatin
n=9 participants at risk
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Death
|
11.1%
1/9 • Number of events 2
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Number of events 2
|
|
Infections and infestations
Septic shock
|
11.1%
1/9 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
22.2%
2/9 • Number of events 4
|
Other adverse events
| Measure |
Doxorubicin and Carboplatin
n=9 participants at risk
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 4
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Asthenia
|
22.2%
2/9 • Number of events 4
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 10
|
|
General disorders
Oedema peripheral
|
33.3%
3/9 • Number of events 6
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Number of events 6
|
|
Infections and infestations
Herpes simplex
|
11.1%
1/9 • Number of events 2
|
|
Infections and infestations
Wound infection
|
11.1%
1/9 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase
|
11.1%
1/9 • Number of events 2
|
|
Investigations
Blood creatine increased
|
11.1%
1/9 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • Number of events 4
|
|
Investigations
Blood urea increased
|
11.1%
1/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
22.2%
2/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.1%
1/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
3/9 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
22.2%
2/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
22.2%
2/9 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal burning sensation
|
11.1%
1/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
11.1%
1/9 • Number of events 2
|
|
Surgical and medical procedures
Stent placement
|
11.1%
1/9 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
1/9 • Number of events 2
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 2
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place