Trial Outcomes & Findings for Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer (NCT NCT00005908)
NCT ID: NCT00005908
Last Updated: 2013-03-19
Results Overview
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 years
Results posted on
2013-03-19
Participant Flow
Participant milestones
| Measure |
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine
Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
|
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
20
|
|
Overall Study
COMPLETED
|
9
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine
Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
|
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel/Capecitabine - A & B
n=30 Participants
Docetaxel/Capecitabine - A- Docetaxel 75 mg/m\^2 intravenous day 1,capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|
|
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
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
50 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 yearsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine
n=9 Participants
Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
|
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
n=20 Participants
Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|---|
|
Number of Participants With Adverse Events
|
9 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Combined data from 2 dose levels in 29 evaluable patients.
Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.
Outcome measures
| Measure |
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine
n=29 Participants
Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
|
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|---|
|
Overall Clinical Response Rate
Complete Response
|
31 Percentage of participants
|
—
|
|
Overall Clinical Response Rate
Partial Response
|
59 Percentage of participants
|
—
|
|
Overall Clinical Response Rate
Complete pathologic response
|
10 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 6 yearsPatients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.
Outcome measures
| Measure |
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine
n=10 Participants
Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
|
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
n=20 Participants
Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|---|
|
Complementary Deoxyribonucleic Acid (cDNA) Expression
Responders
|
8 Participants
|
7 Participants
|
|
Complementary Deoxyribonucleic Acid (cDNA) Expression
Non-responders
|
2 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Specimens from 21 patients. Analysis was "per protocol" and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together.
Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.
Outcome measures
| Measure |
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine
n=21 Participants
Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
|
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Docetaxel 60 mg/m\^2 intravenous day 1 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15
|
|---|---|---|
|
Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models
Responders
|
8 Participants
|
—
|
|
Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models
Non-responders
|
13 Participants
|
—
|
Adverse Events
Docetaxel/Capecitabine - A & B
Serious events: 29 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel/Capecitabine - A & B
n=30 participants at risk
Docetaxel/Capecitabine - A- Docetaxel 75 mg/m\^2 intravenous day 1,capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
|
|---|---|
|
Gastrointestinal disorders
Diarrhea (without colostomy)
|
16.7%
5/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle ache)
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Hand/foot skin reaction
|
43.3%
13/30 • Number of events 16 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Neuropathy-sensory
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Infections and infestations
Infection, Other
|
16.7%
5/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Dehydration
|
3.3%
1/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
3/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
5/30 • Number of events 13 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
13.3%
4/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Infections and infestations
Infection without neutropenia
|
6.7%
2/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Leukocytes (total WBC)
|
40.0%
12/30 • Number of events 44 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Blood and lymphatic system disorders
Lymphatics
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Psychiatric disorders
Mood alteration-depression
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
86.7%
26/30 • Number of events 135 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
SGOT (AST)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
SGPT (ALT)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal/mucositis)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Vascular disorders
Thrombosis/embolism
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Injury, poisoning and procedural complications
Wound-infectious
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Injury, poisoning and procedural complications
Wound-non-infectious
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Anorexia
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
Other adverse events
| Measure |
Docetaxel/Capecitabine - A & B
n=30 participants at risk
Docetaxel/Capecitabine - A- Docetaxel 75 mg/m\^2 intravenous day 1,capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
|
|---|---|
|
Gastrointestinal disorders
Diarrhea (without colostomy)
|
33.3%
10/30 • Number of events 24 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Memory loss
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
13.3%
4/30 • Number of events 6 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
13.3%
4/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Immune system disorders
Allergy-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
73.3%
22/30 • Number of events 26 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
23.3%
7/30 • Number of events 11 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Bilirubin
|
16.7%
5/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.3%
4/30 • Number of events 9 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Chest pain (non-cardiac and non-pleuritic)
|
10.0%
3/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Constipation
|
23.3%
7/30 • Number of events 15 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Creatinine
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Depressed level of consciousness
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Dermatitis, focal (associated with high-dose chemotherapy and bone marrow transplant)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Dizziness/lightheadedness
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Eye disorders
Dry eye
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Edema
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Fatigue (lathargy, malaise, asthenia)
|
60.0%
18/30 • Number of events 53 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)
|
6.7%
2/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
GI-Other
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
36.7%
11/30 • Number of events 26 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Psychiatric disorders
Headache
|
26.7%
8/30 • Number of events 9 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Ear and labyrinth disorders
Hearing-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Blood and lymphatic system disorders
Hematologic-Other
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Renal and urinary disorders
Hematuria (in absence of vaginal bleeding)
|
3.3%
1/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Hemoglobin (hgb)
|
30.0%
9/30 • Number of events 39 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Vascular disorders
Hot flashes/flashes
|
53.3%
16/30 • Number of events 22 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
46.7%
14/30 • Number of events 36 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.3%
1/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.3%
7/30 • Number of events 13 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
3/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Infections and infestations
Infection without neutropenia
|
36.7%
11/30 • Number of events 18 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Infections and infestations
Infection, Other
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Leukocytes (total WBC)
|
70.0%
21/30 • Number of events 103 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Reproductive system and breast disorders
Libido
|
13.3%
4/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Blood and lymphatic system disorders
Lymphatics
|
13.3%
4/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
Metabolic-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Psychiatric disorders
Mood alteration-anxiety/agitation
|
23.3%
7/30 • Number of events 9 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Psychiatric disorders
Mood alteration-depression
|
26.7%
8/30 • Number of events 12 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Mouth dryness
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
13.3%
4/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle ache)
|
30.0%
9/30 • Number of events 17 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
33.3%
10/30 • Number of events 11 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Nausea
|
40.0%
12/30 • Number of events 34 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Neuropathy motor
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
83.3%
25/30 • Number of events 71 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Eye disorders
Ocular-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Pain-Other
|
30.0%
9/30 • Number of events 13 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Cardiac disorders
Palpitation
|
6.7%
2/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Vascular disorders
Phlebitis (superficial)
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Platelets
|
10.0%
3/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
6.7%
2/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Renal and urinary disorders
Renal/GU-Other
|
3.3%
1/30 • Number of events 2 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Reproductive system and breast disorders
Sexual/reproductive function-Other
|
16.7%
5/30 • Number of events 5 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
SGOT (AST)
|
16.7%
5/30 • Number of events 9 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Metabolism and nutrition disorders
SGPT (ALT)
|
20.0%
6/30 • Number of events 12 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Skin-Other
|
10.0%
3/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
43.3%
13/30 • Number of events 22 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
General disorders
Syndromes-Other
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
33.3%
10/30 • Number of events 21 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Eye disorders
Tearing (watery eyes)
|
30.0%
9/30 • Number of events 12 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Blood and lymphatic system disorders
Vaginal bleeding
|
3.3%
1/30 • Number of events 3 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Eye disorders
Vision-blurred vision
|
10.0%
3/30 • Number of events 4 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
8/30 • Number of events 21 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Investigations
Weight loss
|
3.3%
1/30 • Number of events 1 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Nervous system disorders
Neuro-sensory
|
33.3%
10/30 • Number of events 17 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
|
Gastrointestinal disorders
Anorexia
|
26.7%
8/30 • Number of events 15 • 6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
|
Additional Information
JoAnne Zujewski, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-9207
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place