Trial Outcomes & Findings for Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function (NCT NCT00478361)
NCT ID: NCT00478361
Last Updated: 2020-10-09
Results Overview
The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.
Results posted on
2020-10-09
Participant Flow
Recruitment period: April 24, 2007 to November 10, 2011. All recruitment done within Community Clinical Oncology Programs (CCOP) medical clinics, specifically The University of Texas MD Anderson Cancer Center and the Ozarks Regional CCOP.
One patient withdrew from the study without receiving treatment.
Participant milestones
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
Baseline characteristics by cohort
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
n=39 Participants
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR.
Outcome measures
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
n=39 Participants
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Objective Response Rate
|
56.4 percentage of participants
Interval 39.6 to 72.2
|
SECONDARY outcome
Timeframe: Registration Date of each participant for up to three years or death whichever came firstThe overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome.
Outcome measures
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
n=39 Participants
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
Complete Response
|
0.25 Hazard Ratio
Interval 0.07 to 0.95
|
|
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
Partial Response
|
1.09 Hazard Ratio
Interval 0.44 to 2.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle.
Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils.
Outcome measures
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
n=32 Participants
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Safety and Efficacy of Same-day Pegfilgrastim
Neutropenic Fever
|
4 participants
|
|
Safety and Efficacy of Same-day Pegfilgrastim
Treatment Delay
|
0 participants
|
Adverse Events
Gemcitabine, Paclitaxel and Doxorubicin
Serious events: 39 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
n=39 participants at risk
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Granulocytopenia
|
33.3%
13/39 • Number of events 13 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Lymphopenia
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Leukopenia
|
20.5%
8/39 • Number of events 8 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
6/39 • Number of events 6 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Thrombocytopenia
|
15.4%
6/39 • Number of events 6 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
10.3%
4/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
General disorders
Fatigue
|
10.3%
4/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.3%
4/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Mucositis
|
10.3%
4/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
General disorders
Pain
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Hand Foot Syndrome
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.3%
4/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
Other adverse events
| Measure |
Gemcitabine, Paclitaxel and Doxorubicin
n=39 participants at risk
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
|
|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.4%
6/39 • Number of events 7 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
6/39 • Number of events 6 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Platelet Count Decreased
|
33.3%
13/39 • Number of events 28 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Blood and lymphatic system disorders
Anemia
|
82.1%
32/39 • Number of events 73 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
General disorders
Fever
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
25.6%
10/39 • Number of events 10 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin and Subcutaneous Tissue Disorders - Nodule
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Creatinine Increased
|
66.7%
26/39 • Number of events 38 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.9%
14/39 • Number of events 18 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Redness/Irritation
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
General disorders
Edema Limbs
|
25.6%
10/39 • Number of events 12 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Alkaline Phosphatase Increased
|
15.4%
6/39 • Number of events 8 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
13/39 • Number of events 17 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Blood and lymphatic system disorders
BUN
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Mucositis Oral
|
20.5%
8/39 • Number of events 14 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Carbon Monoxide Diffusing Capacity Decreased
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
9/39 • Number of events 12 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Cardiac Troponin I Increased
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Eye disorders
Watering Eyes
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Proteinuria
|
10.3%
4/39 • Number of events 5 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
General disorders
Fatigue
|
43.6%
17/39 • Number of events 33 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.2%
11/39 • Number of events 14 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.8%
5/39 • Number of events 6 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Hematuria
|
15.4%
6/39 • Number of events 8 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
White Blood Cell Decreased
|
12.8%
5/39 • Number of events 8 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
12.8%
5/39 • Number of events 5 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
3/39 • Number of events 5 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Hemoglobinuria
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.9%
7/39 • Number of events 8 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.4%
6/39 • Number of events 9 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Neutrophil Count Decreased
|
10.3%
4/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
17.9%
7/39 • Number of events 8 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
INR Increased
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Hemoglobin Increased
|
5.1%
2/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.1%
2/39 • Number of events 5 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
6/39 • Number of events 7 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Cholesterol High
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Accessory Nerve Disorder
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Nervous System Disorders - Sensory
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Phosphorus High
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
6/39 • Number of events 6 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
CPK Increased
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
12.8%
5/39 • Number of events 6 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Lymphocyte Count Decreased
|
5.1%
2/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Psychiatric disorders
Depression
|
5.1%
2/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Bladder Spasm
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Vascular disorders
Hypertension
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Paresthesia
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Urinary Frequency
|
7.7%
3/39 • Number of events 4 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
General disorders
Gait Disturbance
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Cardiac disorders
Chest Pain
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.1%
2/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Social circumstances
Dehydration
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Weight Loss
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Infections and infestations
Vaginal Infection
|
2.6%
1/39 • Number of events 3 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Infections and infestations
Skin Infection
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Vascular disorders
Thromboembolic Event
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
28.2%
11/39 • Number of events 22 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
2.6%
1/39 • Number of events 2 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Left-Sided
|
2.6%
1/39 • Number of events 1 • Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
|
Additional Information
Nizar M Tannir, MDChair Ad Interim, Genitourinary Medical Oncology
UT MD Anderson Cancer Center, Community Clinical Oncology Program Research Base
Phone: 713-563-7265
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place