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NCT00168896 Clinical Trial

A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

Small Cell Lung Cancer Clinical Trial

Official title:
A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00168896
Other study ID # Haema CBF SCLC UK/AS 01
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received September 9, 2005
Last updated February 13, 2006
Start date October 2001
Est. completion date December 2006

Study information
Verified date September 2001
Source Charite University, Berlin, Germany
Contact Ulrich Keilholz, MD
Phone +49-30-8445-3596
Email ulrich.keilholz@charite.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

Comparison of two combination chemotherapies in the treatment of patients with SLCL

Description:

Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

Recruitment information / eligibility
Status Recruiting
Enrollment 286
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- cytological or histological proven SCLC Stage I or II at 1st diagnosis

- no prior chemotherapy

- measurable tumor disease

- karnofsky performance 70

Exclusion Criteria:

- second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)

- NYHA III

- chronic diarrhea, obstructive bowel syndrome

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Carboplatin plus Irinotecan vs Carboplatin plus Etoposide

Locations
Country Name City State
Germany Hematology & Oncology Charité CBF Berlin, Germany Berlin

Sponsors (3)
Lead Sponsor Collaborator
Charite University, Berlin, Germany Aventis Pharmaceuticals, Pfizer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Endpoint:
Primary Documentation of the remission rate ( Phase II)
Primary Determination of progress free time (Phase III)
Secondary Secondary Endpoint:
Secondary Documentation of progress free time (Phase II)
Secondary Documentation of objective remission rate ( Phase III)
Secondary Documentation of 1-year survival rate
Secondary Documentation of safety of the drug combination
See also
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Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
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Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
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Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3
Terminated NCT00958022 - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer Phase 1