Trial Outcomes & Findings for Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer (NCT NCT01338792)
NCT ID: NCT01338792
Last Updated: 2014-03-10
Results Overview
For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = \<30% decrease or \<20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year
Results posted on
2014-03-10
Participant Flow
The study was activated on June 14, 2006 and was closed to accrual on May 11, 2009 after accruing 47 subjects. Participants were recruited at LAC+USC Medical Center and the USC/Norris Cancer Hospital.
The study had no pre-assignment criteria.
Participant milestones
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
n=47 Participants
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 yearPopulation: All participants who received at least 1 cycle of treatment were included.
For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = \<30% decrease or \<20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.
Outcome measures
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
n=47 Participants
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Best Overall Response
Complete Response
|
0 Participants
|
|
Best Overall Response
Partial Response
|
14 Participants
|
|
Best Overall Response
Stable Disease
|
21 Participants
|
|
Best Overall Response
Progressive Disease
|
8 Participants
|
|
Best Overall Response
Inevaluable
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progressionPopulation: Participants who received at least the first infusion of treatment were included.
Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.
Outcome measures
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
n=47 Participants
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Disease Progression and Overall Survival
Median Survival
|
12.0 Months
Interval 9.8 to 17.2
|
|
Time to Disease Progression and Overall Survival
Median Time to Progression
|
5.8 Months
Interval 3.9 to 8.1
|
|
Time to Disease Progression and Overall Survival
Median Progression Free Survival
|
5.4 Months
Interval 3.8 to 6.9
|
SECONDARY outcome
Timeframe: Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 yearPopulation: All participants who started treatment were included.
Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
n=47 Participants
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
35 Participants
|
Adverse Events
Treatment (Chemotherapy and Enzyme Inhibitor)
Serious events: 35 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
n=47 participants at risk
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Alkaline Phosphatase
|
10.6%
5/47 • Number of events 9 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Ataxia
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Psychiatric disorders
Confusion
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Death not associated with CTCAE term (Disease progression NOS)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Dizziness
|
6.4%
3/47 • Number of events 4 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspsnea (shortness of breath)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
14.9%
7/47 • Number of events 7 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
12.8%
6/47 • Number of events 6 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.8%
6/47 • Number of events 8 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Infection - Other
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Gr 3 or 4 neutrophis (ANC <1.0 x 10e9/L)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Infection with normal ANC or Gr 1 or 2 neutrophils (Blood)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Infection with normal ANC or Gr 1 or 2 neutrophils (Upper airway NOS)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Leukocytes (total WBC)
|
14.9%
7/47 • Number of events 10 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Lymphopenia
|
19.1%
9/47 • Number of events 20 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Whole body/generalized)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Neuropathy: sensory
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
19.1%
9/47 • Number of events 25 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Extremity-limb)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
12.8%
6/47 • Number of events 6 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
12.8%
6/47 • Number of events 6 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Platelets
|
4.3%
2/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Seizure
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Syncope (fainting)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
Other adverse events
| Measure |
Treatment (Chemotherapy and Enzyme Inhibitor)
n=47 participants at risk
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
40.4%
19/47 • Number of events 41 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Alkaline Phosphatase
|
83.0%
39/47 • Number of events 69 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
29.8%
14/47 • Number of events 18 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
42.6%
20/47 • Number of events 33 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Anorexia
|
74.5%
35/47 • Number of events 71 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
74.5%
35/47 • Number of events 64 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.1%
1/47 • Number of events 5 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
8.5%
4/47 • Number of events 7 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
19.1%
9/47 • Number of events 12 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Psychiatric disorders
Confusion
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Constipation
|
23.4%
11/47 • Number of events 13 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Constitutional Symptoms
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
4/47 • Number of events 4 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Creatinine Increased
|
25.5%
12/47 • Number of events 24 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
2.1%
1/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Diarrhea
|
36.2%
17/47 • Number of events 35 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Dizziness
|
42.6%
20/47 • Number of events 24 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Eye disorders
Dry eye syndrome
|
2.1%
1/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.1%
1/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.5%
4/47 • Number of events 6 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Edema: limb
|
14.9%
7/47 • Number of events 9 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
47/47 • Number of events 129 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
4.3%
2/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Flu-like syndrome
|
8.5%
4/47 • Number of events 4 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
76.6%
36/47 • Number of events 76 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
|
21.3%
10/47 • Number of events 10 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
21.3%
10/47 • Number of events 16 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Blood and lymphatic system disorders
Hemoglobin-decreased
|
100.0%
47/47 • Number of events 103 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Vascular disorders
Hypertension
|
2.1%
1/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Incontinence, anal
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Renal and urinary disorders
Incontinence, urinary
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Bladder [urinary])
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Infection with unknown ANC (Bladder [urinary])
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
General disorders
Injection site reaction/extravasation changes
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Leucocytes (total WBC)-decreased
|
61.7%
29/47 • Number of events 95 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Lymphopenia
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Memory impairment
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Whole body/generalized)
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.1%
1/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Infections and infestations
Nasal cavity/paranasal sinus reactions
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Nausea
|
66.0%
31/47 • Number of events 53 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Neuropathy: cranial (CN VIII Hearing and balance)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Neuropathy: sensory
|
85.1%
40/47 • Number of events 87 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
51.1%
24/47 • Number of events 43 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
8.5%
4/47 • Number of events 5 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
14.9%
7/47 • Number of events 8 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Chest/thorax NOS)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Extremity-limb)
|
14.9%
7/47 • Number of events 9 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Pain (Head/headache)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
61.7%
29/47 • Number of events 51 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
61.7%
29/47 • Number of events 45 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Pain (Oral cavity)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Pain (Stomach)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
14.9%
7/47 • Number of events 11 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
10.6%
5/47 • Number of events 5 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Platelet count decreased
|
40.4%
19/47 • Number of events 58 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
12.8%
6/47 • Number of events 8 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
6.4%
3/47 • Number of events 4 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
53.2%
25/47 • Number of events 36 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Sinus tachycardia)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Ear and labyrinth disorders
Tinnitus
|
10.6%
5/47 • Number of events 7 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.3%
2/47 • Number of events 2 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Eye disorders
Blurred vision
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Gastrointestinal disorders
Vomiting
|
34.0%
16/47 • Number of events 21 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.1%
1/47 • Number of events 1 • Baseline, days 1 and 7 of each course, and at last evaluation
|
|
Investigations
Weight loss
|
6.4%
3/47 • Number of events 3 • Baseline, days 1 and 7 of each course, and at last evaluation
|
Additional Information
Jacek Pinski, MD
USC Norris Comprehensive Cancer Center
Phone: 323-865-3900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place