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

NCT02006667 | Completed Phase 2 Results

• 1 other identifier: ML17600
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 7

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.

Conditions

Urinary Tract Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Percentage of Participants Who Were Progression Free at 12 and 24 Months

  Screening, and Months 12 and 24

Secondary Outcomes (4)

• Overall Survival (OS) - Percentage of Participants With an Event

  Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

• Overall Survival - Time to Event

  Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

• Percentage of Participants Surviving at 12 and 24 Months

  Screening, and Months 12 and 24

• Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)

  Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Study Arms (1)

Trastuzumab, Gemcitabine, Cisplatin

EXPERIMENTAL

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; Drug: gemcitabine; Drug: cisplatin

Interventions

trastuzumab DRUG

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

Also known as: Herceptin

Trastuzumab, Gemcitabine, Cisplatin

gemcitabine DRUG

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

Trastuzumab, Gemcitabine, Cisplatin

cisplatin DRUG

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

Trastuzumab, Gemcitabine, Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[3+\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Aschersleben, 06449, Germany

Location

Unknown Facility

Dessau, 06846, Germany

Location

Unknown Facility

Fulda, 36043, Germany

Location

Unknown Facility

Leipzig, 04103, Germany

Location

Unknown Facility

Leipzig, 04277, Germany

Location

Unknown Facility

Marburg, 35043, Germany

Location

Unknown Facility

Weiden, 92637, Germany

Location

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Trastuzumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2001
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-02

Locations

DE (7)