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

February 10, 2010 updated by: Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wels, Austria, A-4600
        • Pfizer Investigational Site
  • Belgium
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liège, Belgium, 4000
        • Pfizer Investigational Site
  • Czech Republic
      • Brno-Bohunice, Czech Republic, 625 00
        • Pfizer Investigational Site
      • Olomouc, Czech Republic, 775 20
        • Pfizer Investigational Site
      • Ostrava - Poruba, Czech Republic, 708 52
        • Pfizer Investigational Site
      • Prague, Czech Republic, 150 06
        • Pfizer Investigational Site
      • Praha 8, Czech Republic, 180 81
        • Pfizer Investigational Site
      • Usti Nad Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
  • Egypt
      • Alexandria, Egypt
        • Pfizer Investigational Site
      • Cairo, Egypt
        • Pfizer Investigational Site
  • France
      • Amiens Cedex 1, France, 80054
        • Pfizer Investigational Site
      • Bobigny, France, 93009
        • Pfizer Investigational Site
      • Bordeaux, France, 33076
        • Pfizer Investigational Site
      • Brest, France, 29200
        • Pfizer Investigational Site
      • Caen Cedex 05, France, 14076
        • Pfizer Investigational Site
      • Limoges, France, 87042
        • Pfizer Investigational Site
      • Marseille Cedex 9, France, 13273
        • Pfizer Investigational Site
      • Meaux, France
        • Pfizer Investigational Site
      • Mulhouse, France, 68070
        • Pfizer Investigational Site
      • Pierre-Bénite, France, 69310
        • Pfizer Investigational Site
      • Rennes, France, 35033
        • Pfizer Investigational Site
      • Rouen Cedex 1, France, 76031
        • Pfizer Investigational Site
      • Saint Brieuc, France, 22015
        • Pfizer Investigational Site
      • Saint Etienne, France, 42055
        • Pfizer Investigational Site
      • Saint Pierre, France, 97448
        • Pfizer Investigational Site
      • Villefranche Sur Saone, France, 69655
        • Pfizer Investigational Site
      • Villejuif, France, 94805
        • Pfizer Investigational Site
  • Germany
      • Bad Berka, Germany, 99437
        • Pfizer Investigational Site
      • Berlin, Germany, 14165
        • Pfizer Investigational Site
      • Bovenden-Lenglern, Germany, 37120
        • Pfizer Investigational Site
      • Ebensfeld, Germany, 96250
        • Pfizer Investigational Site
      • Gauting, Germany, 82131
        • Pfizer Investigational Site
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
      • Grosshansdorf, Germany, 22927
        • Pfizer Investigational Site
      • Hamburg, Germany, 21057
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69126
        • Pfizer Investigational Site
      • Hemer, Germany, 58656
        • Pfizer Investigational Site
      • Loewenstein, Germany, 74245
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40139
        • Pfizer Investigational Site
      • Perugia, Italy, 06122
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1091 HA
        • Pfizer Investigational Site
      • Breda, Netherlands, 4819 EV
        • Pfizer Investigational Site
      • Groningen, Netherlands, 9700 RM
        • Pfizer Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • Pfizer Investigational Site
      • Nieuwegein, Netherlands, 3435 CM
        • Pfizer Investigational Site
  • Poland
      • Lodz, Poland, 93-509
        • Pfizer Investigational Site
      • Otwock, Poland, 05-400
        • Pfizer Investigational Site
      • Poznan, Poland, 60-569
        • Pfizer Investigational Site
      • Warsaw, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 121356
        • Pfizer Investigational Site
      • Moscow 115 478, Russian Federation
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 189646
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08907
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Pfizer Investigational Site
      • Basel, Switzerland, CH-4031
        • Pfizer Investigational Site
      • Bellinzona, Switzerland, CH-6500
        • Pfizer Investigational Site
      • Bern, Switzerland, CH-3010
        • Pfizer Investigational Site
      • Ch-4101 Bruderholz, Switzerland
        • Pfizer Investigational Site
      • Thun, Switzerland, CH-3600
        • Pfizer Investigational Site
  • Taiwan
      • Taichung, Taiwan, 407
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan
        • Pfizer Investigational Site
      • Taoyuan, Taiwan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Irinotecan + cisplatin
irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
Experimental: B
Drug: Etoposide + cisplatin
etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
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)
OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
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

Outcome Measure
Measure Description
Time Frame
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)
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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)
DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
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)
TTP was defined as the time from date of randomization to the date of the first documentation of tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
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
The EORTC QLQ-C30 scales include 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/QL scale and 9 symptom scales: nausea and vomiting, pain, fatigue, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QL represents a high QL (better patient state), and for a symptom scale/item represents a high level of symptomatology/problems (worse patient state).
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
Improvement of ≥ 1 tumor related symptom = clinical benefit responder. Pain improvement = decrease of ≥ 1 National Cancer Institute (NCI) grade from baseline of ≥ 1 symptom of NCI pain category, without pain symptom worsening. Cough, dyspnea and hemoptysis improvement = decrease of ≥ 1 NCI grade from baseline. Positive weight change ≥ 5 percent gain from baseline. Positive analgesic consumption = change from baseline from opioid to non-opioid category.
Every 3 weeks for up to 6 months on study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

February 18, 2010

Last Update Submitted That Met QC Criteria

February 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP4174D-3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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