Trial Outcomes & Findings for Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder (NCT NCT01382706)
NCT ID: NCT01382706
Last Updated: 2025-10-09
Results Overview
Defined as the time period from the start of treatment and documented progression or death without documentation of progression. Summarized with Kaplan-Meier curves. The median will be estimated using a non-parametric method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At 12 weeks
Results posted on
2025-10-09
Participant Flow
Participant milestones
| Measure |
Treatment
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder
Baseline characteristics by cohort
| Measure |
Treatment
n=15 Participants
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksDefined as the time period from the start of treatment and documented progression or death without documentation of progression. Summarized with Kaplan-Meier curves. The median will be estimated using a non-parametric method.
Outcome measures
| Measure |
Treatment
n=15 Participants
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival Rate
|
1.4 months
Interval 1.1 to 2.1
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 7, 10, 13, 16, 19, 22 and then every 6 months for up to 2 yearsSerious Adverse Events will be assessed according to CTCAE version 4.0
Outcome measures
| Measure |
Treatment
n=15 Participants
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Incidence Grade 3 or Higher Serious Adverse Events (SAE)
|
22 Events
|
Adverse Events
Treatment
Serious events: 15 serious events
Other events: 15 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Treatment
n=15 participants at risk
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
5/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • 3 years, 3 months.
|
|
General disorders
Fatigue
|
6.7%
1/15 • 3 years, 3 months.
|
|
Investigations
Neutrophil count decreased
|
13.3%
2/15 • 3 years, 3 months.
|
|
Investigations
White blood cell decreased
|
13.3%
2/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Investigations
Dehydration
|
6.7%
1/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • 3 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • 3 years, 3 months.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • 3 years, 3 months.
|
Other adverse events
| Measure |
Treatment
n=15 participants at risk
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
docetaxel: Given IV
lapatinib ditosylate: Given PO
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
5/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
7/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
13.3%
2/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • 3 years, 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • 3 years, 3 months.
|
|
General disorders
Chills
|
6.7%
1/15 • 3 years, 3 months.
|
|
General disorders
Edema limbs
|
13.3%
2/15 • 3 years, 3 months.
|
|
General disorders
Fatigue
|
66.7%
10/15 • 3 years, 3 months.
|
|
General disorders
Fever
|
6.7%
1/15 • 3 years, 3 months.
|
|
General disorders
Pain
|
13.3%
2/15 • 3 years, 3 months.
|
|
Investigations
White blood cell decreased
|
20.0%
3/15 • 3 years, 3 months.
|
|
Investigations
AST/ALT
|
13.3%
2/15 • 3 years, 3 months.
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
6/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • 3 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • 3 years, 3 months.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • 3 years, 3 months.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • 3 years, 3 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • 3 years, 3 months.
|
|
Psychiatric disorders
Insomnia
|
26.7%
4/15 • 3 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • 3 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • 3 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.0%
9/15 • 3 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
3/15 • 3 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.7%
1/15 • 3 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • 3 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
3/15 • 3 years, 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place