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

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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)

485 participants in 2 patient groups

B
Experimental group
Treatment:
Drug: Etoposide + cisplatin
A
Experimental group
Treatment:
Drug: Irinotecan + cisplatin

Trial contacts and locations

68

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Data sourced from clinicaltrials.gov

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