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A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02006667
Enrollment
13
Registered
2013-12-10
Start date
2001-01-31
Completion date
2010-01-31
Last updated
2015-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Cancer

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.

Interventions

DRUGtrastuzumab

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

DRUGgemcitabine

1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6

DRUGcisplatin

70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression-Free Survival (PFS) - Percentage of Participants With an EventScreening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 monthsPFS 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 EventScreening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 monthsThe 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 MonthsScreening, and Months 12 and 24—

Secondary

MeasureTime frameDescription
Overall Survival (OS) - Percentage of Participants With an EventScreening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 monthsOS was defined as the time from the start of study treatment to date of death due to any cause.
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 monthsPer 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).
Overall Survival - Time to EventScreening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 monthsThe median time, in months, from the start of study treatment to OS event.
Percentage of Participants Surviving at 12 and 24 MonthsScreening, and Months 12 and 24—

Countries

Germany

Participant flow

Participants by arm

ArmCount
Trastuzumab/Gemcitabine/Cisplatin
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
13
Total13

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event3
Overall StudyDeath2
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicTrastuzumab/Gemcitabine/Cisplatin
Age, Continuous68.4 years
STANDARD_DEVIATION 8
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
9 / 13
serious
Total, serious adverse events
8 / 13

Outcome results

Primary

Percentage of Participants Who Were Progression Free at 12 and 24 Months

Time frame: Screening, and Months 12 and 24

Population: FAS

ArmMeasureGroupValue (NUMBER)
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Who Were Progression Free at 12 and 24 Months12 Months38.5 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Who Were Progression Free at 12 and 24 Months24 Months15.4 percentage of participants
Primary

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.

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Population: FAS

ArmMeasureValue (NUMBER)
Trastuzumab/Gemcitabine/CisplatinProgression-Free Survival (PFS) - Percentage of Participants With an Event92.3 percentage of participants
Primary

Progression-Free Survival - Time to Event

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

Population: FAS

ArmMeasureValue (MEDIAN)
Trastuzumab/Gemcitabine/CisplatinProgression-Free Survival - Time to Event11.0 months
Secondary

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.

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

Population: FAS

ArmMeasureValue (NUMBER)
Trastuzumab/Gemcitabine/CisplatinOverall Survival (OS) - Percentage of Participants With an Event84.6 percentage of participants
Secondary

Overall Survival - Time to Event

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

Population: FAS

ArmMeasureValue (MEDIAN)
Trastuzumab/Gemcitabine/CisplatinOverall Survival - Time to Event14.9 months
Secondary

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).

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Population: FAS

ArmMeasureGroupValue (NUMBER)
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)PR23.1 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)CR15.4 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)SD46.2 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)PD15.4 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)CR/PR38.5 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)CR/PR/SD84.6 percentage of participants
Secondary

Percentage of Participants Surviving at 12 and 24 Months

Time frame: Screening, and Months 12 and 24

Population: FAS

ArmMeasureGroupValue (NUMBER)
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Surviving at 12 and 24 Months12 Months76.9 percentage of participants
Trastuzumab/Gemcitabine/CisplatinPercentage of Participants Surviving at 12 and 24 Months24 Months23.1 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026