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

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

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Tract Cancer
• Intervention / Treatment: Drug: trastuzumab

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Aschersleben, Germany, 06449
  • Dessau, Germany, 06846
  • Fulda, Germany, 36043
  • Leipzig, Germany, 04103
  • Leipzig, Germany, 04277
  • Marburg, Germany, 35043
  • Weiden, Germany, 92637

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 to death due to any cause.	Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Progression-Free Survival - Time to Event	The median time, in months, from the first study drug treatment to a PFS event.	Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Percentage of Participants Progression Free at 12 and 24 Months		Months 12 and 24

Secondary Outcome Measures

Outcome Measure	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, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter
Overall Survival - Time to Event	The median time, in months, from the start of study treatment to an OS event.	Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter
Percentage of Participants Surviving at 12 and 24 Months		Months 12 and 24
Percentage of Participants by Best Overall Response to 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).	Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 22, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: ML17599