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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab, Gemcitabine, Cisplatin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months |
| Progression-Free Survival - Time to Event | The median time, in months, from the first dose of study treatment to PFS event. | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months |
| Percentage of Participants Who Were Progression Free at 12 and 24 Months | Screening, and Months 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months |
| Overall Survival - Time to Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aschersleben | 06449 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab/Gemcitabine/Cisplatin | Participants received gemcitabine 1200 milligrams per square meter (mg/m^2), intravenously (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 per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) included all enrolled participants who received study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | FAS | Posted | Number | percentage of participants | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months |
|
Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachyarrhythmia | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| gemcitabine | Drug | 1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6 |
|
| cisplatin | Drug | 70 mg/m2 i.v. on Day 2 of Cycles 1 through 6 |
|
The median time, in months, from the start of study treatment to OS event. |
| Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months |
| Percentage of Participants Surviving at 12 and 24 Months | Screening, and Months 12 and 24 |
| 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). | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months |
| Dessau |
| 06846 |
| Germany |
| Fulda | 36043 | Germany |
| Leipzig | 04103 | Germany |
| Leipzig | 04277 | Germany |
| Marburg | 35043 | Germany |
| Weiden | 92637 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Progression-Free Survival - Time to Event | The median time, in months, from the first dose of study treatment to PFS event. | FAS | Posted | Median | 95% Confidence Interval | months | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months |
|
|
|
| Primary | Percentage of Participants Who Were Progression Free at 12 and 24 Months | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Screening, and Months 12 and 24 |
|
|
|
| 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. | FAS | Posted | Number | percentage of participants | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months |
|
|
|
| Secondary | Overall Survival - Time to Event | The median time, in months, from the start of study treatment to OS event. | FAS | Posted | Median | 95% Confidence Interval | months | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months |
|
|
|
| Secondary | Percentage of Participants Surviving at 12 and 24 Months | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Screening, and Months 12 and 24 |
|
|
|
| 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). | FAS | Posted | Number | percentage of participants | Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months |
|
|
|
| 8 |
| 13 |
| 9 |
| 13 |
| Gastrointestinal hermorrhage | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Chill | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Fever | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| General disorders-other | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Catheter related infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Endocrine disorders-other | Endocrine disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Eyelid function disorder | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Chills | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pain | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| General disorders and administration site conditions-other | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Infections and infestations-others | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Investigations-other | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified-others | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC 2.0 | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail ridging | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Surgical and medical procedures-others | Surgical and medical procedures | NCI CTC 2.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Title | Measurements |
|---|
|
| PD |
|
| CR/PR |
|
| CR/PR/SD |
|