Trial Outcomes & Findings for A Study of Imatinib and Docetaxel in Prostate Cancer (NCT NCT00251225)
NCT ID: NCT00251225
Last Updated: 2017-08-09
Results Overview
TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
COMPLETED
PHASE2
49 participants
Up to 24 months
2017-08-09
Participant Flow
Participant milestones
| Measure |
Hormone Refractory Prostate Cancer Patients
Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Imatinib and Docetaxel in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Hormone Refractory Prostate Cancer Patients
n=49 Participants
Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib
TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Outcome measures
| Measure |
Hormone Refractory Prostate Cancer Patients
n=29 Participants
Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Overall Time To Progression (TTP)
|
6.4 months
Interval 4.8 to 8.4
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib
PSA response rate is the number of participants who experienced a best response of: complete response, CR (PSA less than or equal to 0.2 ng/mL, documented two or more times, a minimum of four weeks apart), partial response, PR (a decline in PSA by at least 50%, confirmed by a second PSA value four or more weeks later) or stable disease (does not qualify for CR, PR, Progression or Symptomatic Deterioration, at least 6 weeks after registration) / total number of analyzable patients.
Outcome measures
| Measure |
Hormone Refractory Prostate Cancer Patients
n=29 Participants
Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Prostate-Specific Antigen (PSA) Response Rate
|
72.4 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib
OS is the amount of time in months from the date of registration to the date of death from any cause.
Outcome measures
| Measure |
Hormone Refractory Prostate Cancer Patients
n=29 Participants
Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Overall Survival (OS)
|
23.1 months
Interval 11.5 to 34.7
|
Adverse Events
Hormone Refractory Prostate Cancer Patients
Serious adverse events
| Measure |
Hormone Refractory Prostate Cancer Patients
n=49 participants at risk
Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
2.0%
1/49
|
|
Investigations
Alkaline phosphatase
|
2.0%
1/49
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
2.0%
1/49
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.0%
1/49
|
|
Cardiac disorders
Cardiovascular/Arrhythmia-Other
|
2.0%
1/49
|
|
Cardiac disorders
Cardiovascular/General-Other
|
2.0%
1/49
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
2.0%
1/49
|
|
General disorders
Heartburn/dyspepsia
|
2.0%
1/49
|
|
General disorders
Hematochezia
|
2.0%
1/49
|
|
Vascular disorders
Hemorrhage, GI, Duodenum
|
2.0%
1/49
|
|
Vascular disorders
Hemorrhage, GI, Upper GI NOS
|
2.0%
1/49
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
2.0%
1/49
|
|
Vascular disorders
Hemorrhage-Other
|
2.0%
1/49
|
|
Investigations
Hypocalcemia
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49
|
|
Infections and infestations
Infection - Other (Specify, __)
|
2.0%
1/49
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
2.0%
1/49
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other
|
2.0%
1/49
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49
|
|
Renal and urinary disorders
Obstruction, GU, Ureter
|
2.0%
1/49
|
|
General disorders
Secondary Malignancy-Other (excludes metastasis from initial primary)
|
2.0%
1/49
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.0%
1/49
|
|
Cardiac disorders
Ventricular arrhythmia, Ventricular fibrillation
|
2.0%
1/49
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49
|
|
Gastrointestinal disorders
Dehydration
|
6.1%
3/49
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.1%
3/49
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.1%
3/49
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
22.4%
11/49
|
Other adverse events
| Measure |
Hormone Refractory Prostate Cancer Patients
n=49 participants at risk
Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.0%
1/49
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.1%
2/49
|
|
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
|
2.0%
1/49
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.1%
2/49
|
|
Blood and lymphatic system disorders
Platelets
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
28.6%
14/49
|
|
Blood and lymphatic system disorders
Hemoglobin
|
34.7%
17/49
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
34.7%
17/49
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
2.0%
1/49
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Atrial flutter
|
2.0%
1/49
|
|
Cardiac disorders
Ventricular arrhythmia, PVCs
|
2.0%
1/49
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Sinus tachycardia
|
6.1%
3/49
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
2.0%
1/49
|
|
Cardiac disorders
Hypertension
|
6.1%
3/49
|
|
Cardiac disorders
Hypotension
|
6.1%
3/49
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
4.1%
2/49
|
|
General disorders
Sweating (diaphoresis)
|
4.1%
2/49
|
|
General disorders
Weight loss
|
6.1%
3/49
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
8.2%
4/49
|
|
General disorders
Rigors/chills
|
8.2%
4/49
|
|
General disorders
Insomnia
|
14.3%
7/49
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
71.4%
35/49
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
2.0%
1/49
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
4.1%
2/49
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
3/49
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.1%
3/49
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
12.2%
6/49
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
18.4%
9/49
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
20.4%
10/49
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.0%
1/49
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/49
|
|
Gastrointestinal disorders
Proctitis
|
2.0%
1/49
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
2/49
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
6.1%
3/49
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
8.2%
4/49
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
8.2%
4/49
|
|
Gastrointestinal disorders
Constipation
|
14.3%
7/49
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
14.3%
7/49
|
|
Gastrointestinal disorders
Dehydration
|
18.4%
9/49
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
20.4%
10/49
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
13/49
|
|
Gastrointestinal disorders
Anorexia
|
30.6%
15/49
|
|
Gastrointestinal disorders
Diarrhea
|
44.9%
22/49
|
|
Gastrointestinal disorders
Nausea
|
49.0%
24/49
|
|
Vascular disorders
Hemorrhage, GI, Lower GI NOS
|
4.1%
2/49
|
|
Vascular disorders
Hemorrhage, GI, Rectum
|
4.1%
2/49
|
|
Infections and infestations
Infection (documented)w Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) Liver
|
2.0%
1/49
|
|
Infections and infestations
Infection (documented) w Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), Urinary tract NOS
|
2.0%
1/49
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
|
2.0%
1/49
|
|
Infections and infestations
Infection with unknown ANC, Upper airway NOS
|
2.0%
1/49
|
|
Infections and infestations
Infection - Other (Specify, __)
|
4.1%
2/49
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
|
6.1%
3/49
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __)
|
2.0%
1/49
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
Edema: limb
|
24.5%
12/49
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
2.0%
1/49
|
|
Investigations
Glucose, serum-low (hypoglycemia)
|
2.0%
1/49
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
4.1%
2/49
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
6.1%
3/49
|
|
Investigations
Alkaline phosphatase
|
8.2%
4/49
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
12.2%
6/49
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized
|
6.1%
3/49
|
|
Nervous system disorders
Confusion
|
2.0%
1/49
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
2.0%
1/49
|
|
Nervous system disorders
Mood alteration, Depression
|
2.0%
1/49
|
|
Nervous system disorders
Dizziness
|
12.2%
6/49
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
14.3%
7/49
|
|
Nervous system disorders
Neuropathy: sensory
|
22.4%
11/49
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
2.0%
1/49
|
|
Eye disorders
Vision-flashing lights/floaters
|
2.0%
1/49
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
4.1%
2/49
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
4.1%
2/49
|
|
General disorders
Pain, Neck
|
2.0%
1/49
|
|
General disorders
Pain - Other (Specify, __)
|
4.1%
2/49
|
|
General disorders
Pain, Abdomen NOS
|
4.1%
2/49
|
|
General disorders
Pain, Joint
|
4.1%
2/49
|
|
General disorders
Pain, Chest/thorax NOS
|
6.1%
3/49
|
|
General disorders
Pain, Muscle
|
6.1%
3/49
|
|
General disorders
Pain, Bone
|
8.2%
4/49
|
|
General disorders
Pain, Head/headache
|
8.2%
4/49
|
|
General disorders
Pain, Extremity-limb
|
10.2%
5/49
|
|
General disorders
Pain, Back
|
18.4%
9/49
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
4.1%
2/49
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.2%
6/49
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.4%
10/49
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.0%
1/49
|
|
Renal and urinary disorders
Urine color change
|
2.0%
1/49
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.1%
2/49
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
6.1%
3/49
|
Additional Information
Leonard J. Appleman, MD, PhD
University of Pittsburgh Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place