Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 3

Conditions: Small Cell Lung Carcinoma

Treatments: Drug: Irinotecan + cisplatin; Drug: Etoposide + cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143455

XRP4174D-3001

Details and patient eligibility

About

To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).

Enrollment: 485 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
• WHO performance status : 0, 1

Exclusion criteria

• No previous radiotherapy is allowed except on bone metastases when newly diagnosed. Radiotherapy is not allowed for vena cava syndrome, a stent is recommended ;
• No prior surgery on the primary tumor except for palliative purpose (stent for vena cava syndrome).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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485 participants in 2 patient groups

B

Experimental group

Treatment:

Drug: Etoposide + cisplatin

A

Experimental group

Treatment:

Drug: Irinotecan + cisplatin