Trial Outcomes & Findings for Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery (NCT NCT00524459)
NCT ID: NCT00524459
Last Updated: 2014-08-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Results posted on
2014-08-29
Participant Flow
Participant milestones
| Measure |
DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel
DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel
DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel
n=6 Participants
DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
|
|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Surgery done after completion of six cycles of study chemotherapy treatment.Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every cycle during study treatment and 8 weeks post-treatment.Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
Adverse Events
DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel
n=6 participants at risk
DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
|
|---|---|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel
n=6 participants at risk
DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
3/6 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
83.3%
5/6 • Number of events 5
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
66.7%
4/6 • Number of events 4
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 5
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
4/6 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Blood calcium
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Blood glucose
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Blood sodium increased
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
16.7%
1/6 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
4/6 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
83.3%
5/6 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
2/6 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
66.7%
4/6 • Number of events 4
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Number of events 4
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neurological symptom
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Amenorrhoea
|
33.3%
2/6 • Number of events 2
|
|
Reproductive system and breast disorders
Metrorrhagia
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
83.3%
5/6 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
50.0%
3/6 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
4/6 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6 • Number of events 5
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hot flush
|
66.7%
4/6 • Number of events 6
|
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