Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Disease Progression

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Trastuzumab

Cisplatin

Antimetabolites

Antineoplastic Agents, Immunological

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.

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

trastuzumab

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

gemcitabine

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

cisplatin

Clinical Trials

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.

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

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

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.

The median time, in months, from the first dose of study treatment to PFS event.

OS was defined as the time from the start of study treatment to date of death due to any cause.

The median time, in months, from the start of study treatment to OS event.

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).

Hoffmann-La Roche

This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.

Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.

Trastuzumab/Gemcitabine/Cisplatin

Age, Continuous

Sex: Female, Male

Full analysis set (FAS) included all enrolled participants who received study treatment.

Medical Communications

Progression-Free Survival (PFS) - Percentage of Participants With an Event

Progression-Free Survival - Time to Event

12 Months

24 Months

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

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

Overall Survival - Time to Event

Percentage of Participants Surviving at 12 and 24 Months

CR/PR

CR/PR/SD

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

Participants received gemcitabine 1200 milligrams per square meter (mg/m\^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.

Spots Global Cancer Trial Database for A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial