Small Cell Lung CarcinomaPhase 3NCT00143455

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

A Phase 3 study testing Etoposide + cisplatin and Irinotecan + cisplatin in people with Small Cell Lung Carcinoma, run by Pfizer at 67 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Small Cell Lung Carcinoma
What is being tested?: Etoposide + cisplatin and Irinotecan + cisplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 485 participants
Where: 67 sitesin 13 countries
Study dates: Jun 2002to Dec 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
WHO performance status : 0, 1

Who cannot join

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 locations and contacts

67 sites in 13 countries.

Country

City, postcode or hospital

67 sites in 13 countries

France17 sites

Pfizer Investigational Site
Amiens, 80054
Pfizer Investigational Site
Bobigny, 93009
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Caen, 14076
Pfizer Investigational Site
Limoges, 87042
Pfizer Investigational Site
Marseille, 13273
Pfizer Investigational Site
Meaux
Pfizer Investigational Site
Mulhouse, 68070
Pfizer Investigational Site
Pierre-Bénite, 69310
Pfizer Investigational Site
Rennes, 35033
Pfizer Investigational Site
Rouen, 76031
Pfizer Investigational Site
Saint-Brieuc, 22015
Pfizer Investigational Site
Saint-Etienne, 42055
Pfizer Investigational Site
Saint-Pierre, 97448
Pfizer Investigational Site
Villefranche-sur-Saône, 69655
Pfizer Investigational Site
Villejuif, 94805

Other trials in France

Germany12 sites

Pfizer Investigational Site
Bad Berka, 99437
Pfizer Investigational Site
Berlin, 14165
Pfizer Investigational Site
Bovenden-Lenglern, 37120
Pfizer Investigational Site
Ebensfeld, 96250
Pfizer Investigational Site
Gauting, 82131
Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Großhansdorf, 22927
Pfizer Investigational Site
Hamburg, 21057
Pfizer Investigational Site
Heidelberg, 69126
Pfizer Investigational Site
Hemer, 58656
Pfizer Investigational Site
Löwenstein, 74245
Pfizer Investigational Site
München, 81675

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Czechia6 sites

Pfizer Investigational Site
Brno-Bohunice, 625 00
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Ostrava - Poruba, 708 52
Pfizer Investigational Site
Prague, 150 06
Pfizer Investigational Site
Prague, 180 81
Pfizer Investigational Site
Ústí nad Labem, 401 13

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Switzerland6 sites

Pfizer Investigational Site
Aarau, CH-5001
Pfizer Investigational Site
Basel, CH-4031
Pfizer Investigational Site
Bellinzona, CH-6500
Pfizer Investigational Site
Bern, CH-3010
Pfizer Investigational Site
Ch-4101 Bruderholz
Pfizer Investigational Site
Thun, CH-3600

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Netherlands5 sites

Pfizer Investigational Site
Amsterdam, 1091 HA
Pfizer Investigational Site
Breda, 4819 EV
Pfizer Investigational Site
Groningen, 9700 RM
Pfizer Investigational Site
Maastricht, 6229 HX
Pfizer Investigational Site
Nieuwegein, 3435 CM

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Poland4 sites

Pfizer Investigational Site
Lodz, 93-509
Pfizer Investigational Site
Otwock, 05-400
Pfizer Investigational Site
Poznan, 60-569
Pfizer Investigational Site
Warsaw, 02-781

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Taiwan4 sites

Pfizer Investigational Site
Taichung, 407
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei
Pfizer Investigational Site
Taoyuan

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Belgium3 sites

Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, 4000

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Russia3 sites

Pfizer Investigational Site
Moscow, 121356
Pfizer Investigational Site
Moscow 115 478
Pfizer Investigational Site
Saint Petersburg, 189646

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Egypt2 sites

Pfizer Investigational Site
Alexandria
Pfizer Investigational Site
Cairo

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Italy2 sites

Pfizer Investigational Site
Bologna, 40139
Pfizer Investigational Site
Perugia, 06122

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Spain2 sites

Pfizer Investigational Site
Barcelona, BARCELONA, 08907
Pfizer Investigational Site
Madrid, Madrid, 28040

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Austria1 site

Pfizer Investigational Site
Wels, A-4600

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About this study

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

Conditions: Small Cell Lung Carcinoma
Being tested: Etoposide + cisplatin, Irinotecan + cisplatin
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Etoposide + cisplatinDrug
etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
Irinotecan + cisplatinDrug
irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

Study groups in NCT00143455
Study group	Role	What they receive
B	Experimental	Not described Receives: Drug: Etoposide + cisplatin
A	Experimental	Not described Receives: Drug: Irinotecan + cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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 outcomes (5)

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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: Every 3 weeks for up to 6 months on study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2002Dec 2008

First posted2 Sep 2005 (estimated)
Study startJun 2002
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 485 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00143455
Sponsor's protocol ID: XRP4174D-3001
Status last verified: Feb 2010
First submitted: 1 Sep 2005
Last updated: 18 Feb 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00143455
Acronym / sponsor ID: XRP4174D-3001
Conditions: Small Cell Lung Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 485 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2002
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 2 Sep 2005 (estimated)
Results: Posted 21 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
B	Experimental	Drug: Etoposide + cisplatin
A	Experimental	Drug: Irinotecan + cisplatin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
WHO performance status : 0, 1

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Etoposide + cisplatinetoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle	Drug	B
Irinotecan + cisplatinirinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle	Drug	A

Primary outcome

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.
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.

5 secondary outcomes

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

Results and safety

Results posted to the registry on 21 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Irinotecan + Cisplatin (Cohort 1)	39	25
Etoposide + Cisplatin (Cohort 1)	39	22
Irinotecan + Cisplatin (Cohort 2)	0	0
Etoposide + Cisplatin (Cohort 2)	0	0

Primary outcome: 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). Median (95% Confidence Interval). Unit: months

Measure	Irinotecan + Cisplatin (Cohort 1) n = 0	Etoposide + Cisplatin (Cohort 1) n = 0	Irinotecan + Cisplatin (Cohort 2) n = 202	Etoposide + Cisplatin (Cohort 2) n = 203
Value	–	–	10.2177 (8.9692 to 11.6632)	9.6591 (8.9363 to 11.0719)

Irinotecan + Cisplatin (Cohort 2) vs Etoposide + Cisplatin (Cohort 2): Hazard Ratio (HR): 1.236 (95% CI 0.995 to 1.536), p = 0.0556, Cox Proportional Hazard Model

Population analysed: FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.

Primary outcome: Overall Survival for the Per Protocol (PP) Population

Measure	Irinotecan + Cisplatin (Cohort 2) n = 176	Etoposide + Cisplatin (Cohort 2) n = 186
Value	10.5791 (9.2977 to 12.2875)	9.4292 (8.5092 to 10.1848)

Irinotecan + Cisplatin (Cohort 2) vs Etoposide + Cisplatin (Cohort 2): Hazard Ratio (HR): 1.350 (95% CI 1.071 to 1.701), p = 0.0110, Cox Proportional Hazard Model

Population analysed: PP population = a subset of the Cohort 2 FAP. The subjects had to be eligible (subject had no major protocol deviations from inclusion and noninclusion criteria), evaluable for response, without any major protocol deviations during the study.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Irinotecan + Cisplatin (Cohort 1)	9 of 39 (23.1%)	39 of 39 (100%)	Not reported
Etoposide + Cisplatin (Cohort 1)	4 of 38 (10.5%)	38 of 38 (100%)	Not reported
Irinotecan + Cisplatin (Cohort 2)	45 of 202 (22.3%)	202 of 202 (100%)	Not reported
Etoposide + Cisplatin (Cohort 2)	29 of 203 (14.3%)	203 of 203 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

67 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoposide + cisplatin and Irinotecan + cisplatin in people with Small Cell Lung Carcinoma, run by Pfizer at 67 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in France, Germany, Czechia, Switzerland, Netherlands and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00143455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.