Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer

Treatments: Drug: Gemcitabine; Drug: Cisplatin; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246974

D7913L00063

1839IL/0063

Details and patient eligibility

About

The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
• Locally advanced or metastatic disease
• At least one measurable lesion as defined by RECIST
• Chemotherapy-naiv

Exclusion criteria

• Previous chemotherapy or other systemic antitumour therapy
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

1

Active Comparator group

Description:

Cisplatin + Gemcitabin

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

2

Experimental group

Description:

Cisplatin + Gemcitabin + Gefitinib

Treatment:

Drug: Gefitinib

Drug: Cisplatin

Drug: Gemcitabine