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Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

Phase 2
18 Years
80 Years
Open (Enrolling)
Recurrent Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder

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Trial Information

Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

Inclusion Criteria:

- Transitional cell carcinoma of the urothelium or bladder histologically proven stage
IV AJCC [locally advanced (T4b and / or N + M0) unresectable or metastatic (M1)]

- Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2
+ and FISH +. Centralized analysis.

- Measurable disease with at least one lesion with a diameter> 2 cm for conventional
methods (clinical examination, CT or MRI) or> 1 cm for the helical scanner. In case
of single metastasis, metastatic disease should be histologically proven

- Age ≥ 18 years and ≤80 years

- Life expectancy> 3 months,

- Index performance status <2 according to ECOG PS,

- No prior chemotherapy other than adjuvant and / or neoadjuvant chemotherapy, without
Herceptin ® and complete for more than 6 months (naive to any previous chemotherapy
in the metastatic setting)

- No radiotherapy within 4 weeks prior to inclusion,

- Normal cardiac function as measured by ejection fraction (LVEF> 50%),

- Blood and liver satisfactory constants:

Hematological criteria: - Neutrophils> 1.5 x 109 / L, - Chips> 100 x 109 / L - Hemoglobin>
10 g / dL, Liver function: - Alkaline phosphatase (unless bone metastases) <2 x N - Total
bilirubin <1.5 x N - transaminases (AST, ALT) <1.5 x N, renal Constants: - Creatinine
clearance > 30 ml / min (Cockcroft and Gault, cf. Annex XV protocol)

- Patient's written consent after full information.

Exclusion Criteria:

- Concurrent treatment with an experimental drug, participation in another clinical
trial within <30 days

- Patients previously treated with Herceptin ®, or another treatment targeting growth
factors EGF (eg Iressa ®, Tarceva ®)

- Existence of a severe pulmonary disease, liver or kidney is likely to be exacerbated
by the treatment,

- Other medical conditions: congestive heart failure or angina pectoris even if
medically controlled failure, history of myocardial infarction before entering the
trial, hypertension or uncontrolled arrhythmias, significant valvular disease,

- Patient with dyspnoea at rest or requiring oxygen therapy or with respiratory

- Presence of a severe infection requiring antibiotics,

- Presence of CNS metastases or meningeal

- History of another malignancy uncured or cured for less than 5 years (except basal
cell carcinoma, papillary thyroid carcinoma in situ of the cervix treated)

- Pregnant or lactating or not using effective contraception Women,

- For Cisplatin only: carrying a serious neurological disease, current events devices>
NCI grade 2 neuropathy, hearing loss, creatinine clearance <60 ml / min, the patient
can not support a patient hydration.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free survival

Outcome Time Frame:

Participants will be followed from radomization until progression or death, up to 3 years

Safety Issue:


Principal Investigator

Stéphane Oudard, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Européen Georges Pompidou, Paris (France)


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Recurrent Bladder Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urothelial carcinoma
  • Trastuzumab
  • Treatment
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell