Trial Outcomes & Findings for Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC) (NCT NCT00307294)
NCT ID: NCT00307294
Last Updated: 2017-11-24
Results Overview
The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-11-24
Participant Flow
Participant milestones
| Measure |
Thalidomide and Doxil
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Thalidomide and Doxil
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)
Baseline characteristics by cohort
| Measure |
Thalidomide and Doxil
n=39 Participants
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Patients that received greater than one cycle of therapy.
The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.
Outcome measures
| Measure |
Thalidomide and Doxil
n=32 Participants
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Response Rate
|
9.3 percentage of participants
Interval 2.0 to 25.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Patients that received greater than one cycle of therapy and met criteria for stable or progressive disease according to Prostate-Specific Antigen Working Group criteria.
PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.
Outcome measures
| Measure |
Thalidomide and Doxil
n=32 Participants
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Best Overall PSA Response
Stable disease
|
48.8 percentage of patients
Interval 20.0 to 60.0
|
|
Best Overall PSA Response
Progressive Disesase
|
43.7 percentage of patients
Interval 26.0 to 60.0
|
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
Thalidomide and Doxil
n=39 Participants
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Overall Survival
|
12 months
Interval 7.9 to 18.9
|
SECONDARY outcome
Timeframe: Up to 18 monthsTime from start of treatment until the disease progression per RECIST criteria.
Outcome measures
| Measure |
Thalidomide and Doxil
n=39 Participants
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Time to Progression
|
3.7 months
Interval 2.2 to 5.5
|
Adverse Events
Thalidomide and Doxil
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thalidomide and Doxil
n=39 participants at risk
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39
|
|
General disorders
Edema: limb
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.6%
1/39
|
|
General disorders
Pain - Other
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Bone
|
2.6%
1/39
|
|
Gastrointestinal disorders
Pain, Intestine
|
2.6%
1/39
|
|
Gastrointestinal disorders
Pain, Pelvis
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.1%
2/39
|
Other adverse events
| Measure |
Thalidomide and Doxil
n=39 participants at risk
Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
|
|---|---|
|
Nervous system disorders
Pain, Head/headache
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Joint
|
23.1%
9/39
|
|
Gastrointestinal disorders
Pain, Oral cavity
|
2.6%
1/39
|
|
Gastrointestinal disorders
Pain, Pelvis
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Pain, Throat/pharynx/larynx
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
5/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.8%
5/39
|
|
General disorders
Edema, larynx
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
2.6%
1/39
|
|
Renal and urinary disorders
Incontinence, urinary
|
5.1%
2/39
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/39
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
10.3%
4/39
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
7.7%
3/39
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.6%
1/39
|
|
Renal and urinary disorders
Urine color change
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
7.7%
3/39
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
12.8%
5/39
|
|
Blood and lymphatic system disorders
Hemoglobin
|
46.2%
18/39
|
|
Investigations
Leukocytes (total WBC)
|
25.6%
10/39
|
|
Investigations
Lymphopenia
|
5.1%
2/39
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
17.9%
7/39
|
|
Investigations
Platelets
|
5.1%
2/39
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
2.6%
1/39
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Sinus bradycardia
|
2.6%
1/39
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Supraventricular tachycardia
|
2.6%
1/39
|
|
Vascular disorders
Hypotension
|
7.7%
3/39
|
|
General disorders
Constitutional Symptoms - Other
|
5.1%
2/39
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
64.1%
25/39
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
10.3%
4/39
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39
|
|
General disorders
Rigors/chills
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
5.1%
2/39
|
|
Investigations
Weight gain
|
2.6%
1/39
|
|
Investigations
Weight loss
|
12.8%
5/39
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
7.7%
3/39
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.8%
5/39
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.7%
3/39
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
33.3%
13/39
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
2.6%
1/39
|
|
Vascular disorders
Hot flashes/flushes
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Anorexia
|
23.1%
9/39
|
|
Gastrointestinal disorders
Constipation
|
53.8%
21/39
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/39
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
7.7%
3/39
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.1%
2/39
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
5.1%
2/39
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
12.8%
5/39
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
2.6%
1/39
|
|
Gastrointestinal disorders
Nausea
|
25.6%
10/39
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
12.8%
5/39
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
4/39
|
|
Renal and urinary disorders
Hemorrhage, GU, Urinary NOS
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory, Nose
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other
|
2.6%
1/39
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils , Lung (pneumonia)
|
2.6%
1/39
|
|
Infections and infestations
Infection - Other
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Dental-tooth
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
5.1%
2/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
|
7.7%
3/39
|
|
Infections and infestations
Infection with unknown ANC, Sinus
|
2.6%
1/39
|
|
General disorders
Edema: limb
|
33.3%
13/39
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
7.7%
3/39
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.1%
2/39
|
|
Investigations
Alkaline phosphatase
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
7.7%
3/39
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Extraocular
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-lower
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
2.6%
1/39
|
|
Nervous system disorders
Dizziness
|
20.5%
8/39
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
2.6%
1/39
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/39
|
|
Psychiatric disorders
Mood alteration, Anxiety
|
2.6%
1/39
|
|
Psychiatric disorders
Mood alteration, Depression
|
7.7%
3/39
|
|
Nervous system disorders
Neurology - Other
|
12.8%
5/39
|
|
Nervous system disorders
Neuropathy: motor
|
5.1%
2/39
|
|
Nervous system disorders
Neuropathy: sensory
|
35.9%
14/39
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
5.1%
2/39
|
|
Nervous system disorders
Tremor
|
10.3%
4/39
|
|
Eye disorders
Ocular/Visual - Other
|
5.1%
2/39
|
|
Eye disorders
Vision-blurred vision
|
2.6%
1/39
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.6%
1/39
|
|
General disorders
Pain - Other
|
10.3%
4/39
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
15.4%
6/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Bone
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Pain, Chest wall
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Extremity-limb
|
7.7%
3/39
|
|
General disorders
Pain, Face
|
5.1%
2/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place