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

• ClinicalTrials.gov Identifier: NCT02013765
• Recruitment Status: Terminated
• First Posted: December 17, 2013
• Results First Posted: September 25, 2014
• Last Update Posted: September 25, 2014
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression
• Study Start Date: January 2001
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Trastuzumab Monotherapy; Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks.	Drug: trastuzumab; Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.; Other Name: Herceptin

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment ]
   PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.
2. Progression-Free Survival - Time to Event [ Time Frame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment ]
   The median time, in months, from the first study drug treatment to a PFS event.
3. Percentage of Participants Progression Free at 12 and 24 Months [ Time Frame: Months 12 and 24 ]

Secondary Outcome Measures :

1. Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter ]
   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, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter ]
   The median time, in months, from the start of study treatment to an OS event.
3. Percentage of Participants Surviving at 12 and 24 Months [ Time Frame: Months 12 and 24 ]
4. Percentage of Participants by Best Overall Response to Treatment [ Time Frame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment ]
   Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (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 decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% 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. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).

Eligibility Criteria

• 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 >=18 years of age;
• metastatic urothelial cancer;
• disease progression during or after 1 prior platinum-based chemotherapy;
• measurable 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

Locations

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

• Study Chair: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02013765
• Other Study ID Numbers: ML17599
• First Posted: December 17, 2013
• Results First Posted: September 25, 2014
• Last Update Posted: September 25, 2014
• Last Verified: September 2014

Additional relevant MeSH terms:

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Trastuzumab; Antineoplastic Agents, Immunological; Antineoplastic Agents