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

Urinary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02013765
• Other study ID #: ML17599
• Status: Terminated
• Phase: Phase 2
• First received: December 3, 2013
• Last updated: September 22, 2014
• Start date: January 2001
• Est. completion date: January 2010

Study information

• Verified date: September 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut (PEI)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Tract Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 to death due to any cause.	Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment	No
Primary	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	No
Primary	Percentage of Participants Progression Free at 12 and 24 Months		Months 12 and 24	No
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.	Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter	No
Secondary	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	No
Secondary	Percentage of Participants Surviving at 12 and 24 Months		Months 12 and 24	No
Secondary	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	No