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

Urinary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006667
• Other study ID #: ML17600
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2013
• Last updated: February 9, 2015
• Start date: January 2001
• Est. completion date: January 2010

Study information

• Verified date: February 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesministerium für Gesundheit (Federal Ministry of Health)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• 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 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.

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
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
• gemcitabine
1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6
• cisplatin
70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

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 death due to any cause.	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months	No
Primary	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	No
Primary	Percentage of Participants Who Were Progression Free at 12 and 24 Months		Screening, and 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, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months	No
Secondary	Overall Survival - Time to Event	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	No
Secondary	Percentage of Participants Surviving at 12 and 24 Months		Screening, and Months 12 and 24	No
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).	Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months	No