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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2010-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Urinary Tract Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trastuzumab, Gemcitabine, Cisplatin

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.

Group Type EXPERIMENTAL

trastuzumab

Intervention Type 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

gemcitabine

Intervention Type DRUG

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

cisplatin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

gemcitabine

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

Intervention Type DRUG

cisplatin

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

Intervention Type DRUG

Other Intervention Names

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Herceptin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No