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

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ClinicalTrials.gov Identifier: NCT02006667
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Tract Cancer Drug: trastuzumab Drug: gemcitabine Drug: cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2001
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Trastuzumab, Gemcitabine, Cisplatin
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.
 Drug: trastuzumab
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
Other Name: Herceptin

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months ]
    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.

  2. Progression-Free Survival - Time to Event [ Time Frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months ]
    The median time, in months, from the first dose of study treatment to PFS event.

  3. Percentage of Participants Who Were Progression Free at 12 and 24 Months [ Time Frame: Screening, and Months 12 and 24 ]

Secondary Outcome Measures :
  1. Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months ]
    OS was defined as the time from the start of study treatment to date of death due to any cause.

  2. Overall Survival - Time to Event [ Time Frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months ]
    The median time, in months, from the start of study treatment to OS event.

  3. Percentage of Participants Surviving at 12 and 24 Months [ Time Frame: Screening, and Months 12 and 24 ]
  4. Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) [ Time Frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006667


Locations
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Germany
Aschersleben, Germany, 06449
Dessau, Germany, 06846
Fulda, Germany, 36043
Leipzig, Germany, 04103
Leipzig, Germany, 04277
Marburg, Germany, 35043
Weiden, Germany, 92637
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02006667    
Other Study ID Numbers: ML17600
First Posted: December 10, 2013    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Gemcitabine
Trastuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological