Trial Outcomes & Findings for Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma (NCT NCT00183872)
NCT ID: NCT00183872
Last Updated: 2018-02-19
Results Overview
Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
every 2 cycles
Results posted on
2018-02-19
Participant Flow
Participants were recruited at the University of Southern California cancer center facilities between April 14, 2005 and January 11, 2012.
There are no pre-assignment requirements for this study.
Participant milestones
| Measure |
Arm 1 - Irinotecan and Docetaxel
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Arm 1 - Irinotecan and Docetaxel
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Drug delayed more than 28 days
|
2
|
Baseline Characteristics
Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Arm 1 - Irinotecan and Docetaxel
n=40 Participants
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 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
|
12 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 2 cyclesPopulation: Population analyzed included all participants who received at least 6 weeks of treatment (or who were discontinued due to progressive disease or for reason of toxicity within the first 6 weeks of study). Two subjects had no tumor evaluation and follow up data available. Analysis was per protocol.
Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.
Outcome measures
| Measure |
Arm 1 - Irinotecan and Docetaxel
n=38 Participants
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Objective Response (Complete, Partial, Stable and Progression)
CR
|
0 participants
|
|
Objective Response (Complete, Partial, Stable and Progression)
PR
|
7 participants
|
|
Objective Response (Complete, Partial, Stable and Progression)
SD
|
22 participants
|
|
Objective Response (Complete, Partial, Stable and Progression)
PD
|
9 participants
|
SECONDARY outcome
Timeframe: every 2 cyclesPopulation: Population analyzed included all participants who received at least 6 weeks of treatment (or who were discontinued due to progressive disease or for reason of toxicity within the first 6 weeks of study). Two subjects had no tumor evaluation and follow up data available. Analysis was per protocol.
Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause. If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.
Outcome measures
| Measure |
Arm 1 - Irinotecan and Docetaxel
n=38 Participants
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Progression Free Survival
|
4.1 Months
Interval 2.9 to 6.0
|
Adverse Events
Arm 1 - Irinotecan and Docetaxel
Serious events: 29 serious events
Other events: 38 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm 1 - Irinotecan and Docetaxel
n=40 participants at risk
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Investigations
Alkaline Phosphatase Increased
|
2.5%
1/40 • Number of events 3 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
AST, SGOT (serum glutamic oxaloacestic transaminase)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Leukocytes (total WBC)
|
10.0%
4/40 • Number of events 8 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
12.5%
5/40 • Number of events 12 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.0%
8/40 • Number of events 9 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Death not associated with CTCAE term (Death NOS)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Death not associated with CTCAE term (Disease progression NOS)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Death not associated with CTCAE term (Sudden death)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Anorexia
|
12.5%
5/40 • Number of events 5 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
4/40 • Number of events 4 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Number of events 3 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Number of events 5 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Infections and infestations
Infection (Blood)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Nervous system disorders
Neuropathy: sensory
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Pain (Abodmen NOS)
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
22.5%
9/40 • Number of events 15 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Nervous system disorders
Pain (Head/headache)
|
10.0%
4/40 • Number of events 4 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
52.5%
21/40 • Number of events 61 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • Number of events 17 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
15.0%
6/40 • Number of events 12 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
2.5%
1/40 • Number of events 5 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
Other adverse events
| Measure |
Arm 1 - Irinotecan and Docetaxel
n=40 participants at risk
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
90.0%
36/40 • Number of events 174 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Leukocytes (total WBC)
|
27.5%
11/40 • Number of events 20 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
27.5%
11/40 • Number of events 33 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Platelets
|
12.5%
5/40 • Number of events 9 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
67.5%
27/40 • Number of events 110 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Fever
|
15.0%
6/40 • Number of events 7 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Psychiatric disorders
Insomnia
|
25.0%
10/40 • Number of events 20 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Rigors/chills
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Weight loss
|
27.5%
11/40 • Number of events 19 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Vascular disorders
Flushing
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
67.5%
27/40 • Number of events 98 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
15.0%
6/40 • Number of events 14 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.5%
3/40 • Number of events 10 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Anorexia
|
60.0%
24/40 • Number of events 63 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
10/40 • Number of events 21 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Dehydration
|
22.5%
9/40 • Number of events 14 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
22/40 • Number of events 54 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam (Oral cavity)
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Oral cavity)
|
10.0%
4/40 • Number of events 8 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Nausea
|
55.0%
22/40 • Number of events 69 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Gastrointestinal disorders
Vomiting
|
32.5%
13/40 • Number of events 42 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory (Nose)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
General disorders
Edema: limb
|
27.5%
11/40 • Number of events 16 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
37.5%
15/40 • Number of events 42 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
40.0%
16/40 • Number of events 50 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.0%
2/40 • Number of events 4 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Alkaline Phosphatase
|
52.5%
21/40 • Number of events 65 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Bilirubin
|
10.0%
4/40 • Number of events 7 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Calcium,serum-high (hypercalcemia)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.0%
2/40 • Number of events 3 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Investigations
Creatinine
|
7.5%
3/40 • Number of events 4 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
22.5%
9/40 • Number of events 25 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.0%
2/40 • Number of events 4 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Nervous system disorders
Dizziness
|
15.0%
6/40 • Number of events 8 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Psychiatric disorders
Mood alteration (Depression)
|
5.0%
2/40 • Number of events 4 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Nervous system disorders
Neuropathy
|
60.0%
24/40 • Number of events 98 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Eye disorders
Vision-blurred vision
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Eye disorders
Vision-flashing lights/floaters
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last dose of study drug is given
Assessed from date on study until 30 days after last dose of drug is given. Assessment is based on CTCAE version 3.0.
|
Additional Information
Victoria Soto - Project Specialist
USC/Norris Comprehensive Cancer Center
Phone: (323) 865-0454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place