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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00143455
First Posted: September 2, 2005
Last Update Posted: February 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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).

Condition Intervention Phase
Small Cell Lung Carcinoma Drug: Etoposide + cisplatin Drug: Irinotecan + cisplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival (OS) for the Full Analysis Population (FAP) [ Time Frame: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment) ]
  • Overall Survival for the Per Protocol (PP) Population [ Time Frame: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment) ]

Secondary Outcome Measures:
  • Number of Subjects With Overall Confirmed Response [ Time Frame: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression) ]
  • Duration of Response (DR) [ Time Frame: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression) ]
  • Time to Tumor Progression (TTP) [ Time Frame: Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression) ]
  • European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) [ Time Frame: Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up ]
  • Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics) [ Time Frame: Every 3 weeks for up to 6 months on study treatment ]

Enrollment: 485
Study Start Date: June 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B Drug: Etoposide + cisplatin
etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
Experimental: A Drug: Irinotecan + cisplatin
irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143455


  Show 68 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00143455     History of Changes
Other Study ID Numbers: XRP4174D-3001
First Submitted: September 1, 2005
First Posted: September 2, 2005
Results First Submitted: December 11, 2009
Results First Posted: January 21, 2010
Last Update Posted: February 18, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Irinotecan
Etoposide phosphate
Cisplatin
Camptothecin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors