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Completed

NCT Number: NCT02006667

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

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.

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Key information

Conditions

Urinary Tract Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aschersleben, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Herceptin

Gemcitabine

Drug

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

Cisplatin

Drug

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

Primary outcomes

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

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

    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.

  2. Progression-Free Survival - Time to Event

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

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

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

    Time frame: Screening, and Months 12 and 24

Secondary outcomes

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

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

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

  2. Overall Survival - Time to Event

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

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

  3. Percentage of Participants Surviving at 12 and 24 Months

    Time frame: Screening, and Months 12 and 24

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

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

    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).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2013
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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