Back to resultsA Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Primary Purpose
Urinary Tract Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
trastuzumab
gemcitabine
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients with >=18 years of age;
- metastatic urothelial carcinoma;
- measurable metastases or local recurrent disease;
- no prior chemotherapy for metastatic disease;
- HER2 overexpression (IHC [2+] or [3+]).
Exclusion Criteria:
- concomitant chemotherapy or immunotherapy;
- active or uncontrolled infection;
- solely CNS metastases;
- clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trastuzumab, Gemcitabine, Cisplatin
Arm Description
Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.
Progression-Free Survival - Time to Event
The median time, in months, from the first dose of study treatment to PFS event.
Percentage of Participants Who Were Progression Free at 12 and 24 Months
Secondary Outcome Measures
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the start of study treatment to date of death due to any cause.
Overall Survival - Time to Event
The median time, in months, from the start of study treatment to OS event.
Percentage of Participants Surviving at 12 and 24 Months
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02006667
Brief Title
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Official Title
An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trastuzumab, Gemcitabine, Cisplatin
Arm Type
Experimental
Arm Description
Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6.
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
70 mg/m2 i.v. on Day 2 of Cycles 1 through 6
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Description
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.
Time Frame
Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Title
Progression-Free Survival - Time to Event
Description
The median time, in months, from the first dose of study treatment to PFS event.
Time Frame
Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Title
Percentage of Participants Who Were Progression Free at 12 and 24 Months
Time Frame
Screening, and Months 12 and 24
Secondary Outcome Measure Information:
Title
Overall Survival (OS) - Percentage of Participants With an Event
Description
OS was defined as the time from the start of study treatment to date of death due to any cause.
Time Frame
Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Title
Overall Survival - Time to Event
Description
The median time, in months, from the start of study treatment to OS event.
Time Frame
Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Title
Percentage of Participants Surviving at 12 and 24 Months
Time Frame
Screening, and Months 12 and 24
Title
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
Description
Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).
Time Frame
Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients with >=18 years of age;
metastatic urothelial carcinoma;
measurable metastases or local recurrent disease;
no prior chemotherapy for metastatic disease;
HER2 overexpression (IHC [2+] or [3+]).
Exclusion Criteria:
concomitant chemotherapy or immunotherapy;
active or uncontrolled infection;
solely CNS metastases;
clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Aschersleben
ZIP/Postal Code
06449
Country
Germany
City
Dessau
ZIP/Postal Code
06846
Country
Germany
City
Fulda
ZIP/Postal Code
36043
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Leipzig
ZIP/Postal Code
04277
Country
Germany
City
Marburg
ZIP/Postal Code
35043
Country
Germany
City
Weiden
ZIP/Postal Code
92637
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
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