search
Back to results

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

Primary Purpose

Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etoposide + cisplatin
Irinotecan + cisplatin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

B

A

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS) for the Full Analysis Population (FAP)
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.
Overall Survival for the Per Protocol (PP) Population
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.

Secondary Outcome Measures

Number of Subjects With Overall Confirmed Response
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.
Duration of Response (DR)
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.
Time to Tumor Progression (TTP)
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.
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
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).
Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)
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.

Full Information

First Posted
September 1, 2005
Last Updated
February 10, 2010
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00143455
Brief Title
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Etoposide + cisplatin
Intervention Description
etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
Intervention Type
Drug
Intervention Name(s)
Irinotecan + cisplatin
Intervention Description
irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
Primary Outcome Measure Information:
Title
Overall Survival (OS) for the Full Analysis Population (FAP)
Description
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.
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)
Title
Overall Survival for the Per Protocol (PP) Population
Description
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.
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 Measure Information:
Title
Number of Subjects With Overall Confirmed Response
Description
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.
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)
Title
Duration of Response (DR)
Description
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.
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)
Title
Time to Tumor Progression (TTP)
Description
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.
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)
Title
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
Description
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).
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
Title
Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)
Description
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.
Time Frame
Every 3 weeks for up to 6 months on study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brno-Bohunice
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Prague
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Alexandria
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Cairo
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Pfizer Investigational Site
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Pfizer Investigational Site
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Pfizer Investigational Site
City
Caen Cedex 05
ZIP/Postal Code
14076
Country
France
Facility Name
Pfizer Investigational Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Pfizer Investigational Site
City
Meaux
Country
France
Facility Name
Pfizer Investigational Site
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Pfizer Investigational Site
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Pfizer Investigational Site
City
Rouen Cedex 1
ZIP/Postal Code
76031
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Facility Name
Pfizer Investigational Site
City
Villefranche Sur Saone
ZIP/Postal Code
69655
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Pfizer Investigational Site
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bovenden-Lenglern
ZIP/Postal Code
37120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ebensfeld
ZIP/Postal Code
96250
Country
Germany
Facility Name
Pfizer Investigational Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Pfizer Investigational Site
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Pfizer Investigational Site
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
21057
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hemer
ZIP/Postal Code
58656
Country
Germany
Facility Name
Pfizer Investigational Site
City
Loewenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Groningen
ZIP/Postal Code
9700 RM
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Pfizer Investigational Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
Moscow 115 478
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
189646
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Ch-4101 Bruderholz
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Thun
ZIP/Postal Code
CH-3600
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=XRP4174D-3001&StudyName=Study%20Of%20Irinotecan%20Hydrochloride%20%28Campto%28R%29%29%20And%20Cisplatin%20Versus%20Etoposide%20And%20Cisplatin%20In%20Small%20Cell%20Lung%20Cancer
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs