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

NCT00143455 | Completed Phase 3 Results DMC

• 1 other identifier: XRP4174D-3001
• Study Type: interventional
• Target: 485
• Locations: 13 countries
• Sites: 67

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).

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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)

  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)

  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)

  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)

  Every 3 weeks for up to 6 months on study treatment

Study Arms (2)

B

EXPERIMENTAL

Drug: Etoposide + cisplatin

A

EXPERIMENTAL

Drug: Irinotecan + cisplatin

Interventions

Etoposide + cisplatin DRUG

etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle

B

Irinotecan + cisplatin DRUG

irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (67)

Pfizer Investigational Site

Wels, A-4600, Austria

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Brno-Bohunice, 625 00, Czechia

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Olomouc, 775 20, Czechia

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Ostrava - Poruba, 708 52, Czechia

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Prague, 150 06, Czechia

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Prague, 180 81, Czechia

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Ústí nad Labem, 401 13, Czechia

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Alexandria, Egypt

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Cairo, Egypt

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Amiens, 80054, France

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Bobigny, 93009, France

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Bordeaux, 33076, France

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Brest, 29200, France

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Caen, 14076, France

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Limoges, 87042, France

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Marseille, 13273, France

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Meaux, France

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Mulhouse, 68070, France

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Pierre-Bénite, 69310, France

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Rennes, 35033, France

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Rouen, 76031, France

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Saint-Brieuc, 22015, France

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Saint-Etienne, 42055, France

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Saint-Pierre, 97448, France

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Villefranche-sur-Saône, 69655, France

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Villejuif, 94805, France

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Bad Berka, 99437, Germany

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Berlin, 14165, Germany

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Bovenden-Lenglern, 37120, Germany

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Ebensfeld, 96250, Germany

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Gauting, 82131, Germany

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Göttingen, 37075, Germany

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Großhansdorf, 22927, Germany

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Hamburg, 21057, Germany

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Heidelberg, 69126, Germany

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Hemer, 58656, Germany

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Löwenstein, 74245, Germany

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München, 81675, Germany

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Bologna, 40139, Italy

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Perugia, 06122, Italy

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Amsterdam, 1091 HA, Netherlands

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Breda, 4819 EV, Netherlands

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Groningen, 9700 RM, Netherlands

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Maastricht, 6229 HX, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Lodz, 93-509, Poland

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Otwock, 05-400, Poland

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Poznan, 60-569, Poland

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Warsaw, 02-781, Poland

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Moscow, 121356, Russia

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Moscow 115 478, Russia

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Saint Petersburg, 189646, Russia

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Barcelona, BARCELONA, 08907, Spain

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Madrid, Madrid, 28040, Spain

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Aarau, CH-5001, Switzerland

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Basel, CH-4031, Switzerland

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Bellinzona, CH-6500, Switzerland

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Bern, CH-3010, Switzerland

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Ch-4101 Bruderholz, Switzerland

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Thun, CH-3600, Switzerland

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Taichung, 407, Taiwan

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Taipei, 100, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PE regimen; Irinotecan; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: June 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 18, 2010
• Results First Posted: January 21, 2010

Record last verified: 2010-02

Locations

IT (2); FR (17); AU (1); CZ (6); BE (3); PL (4); RU (3); TW (4); ES (2); NL (5); EG (2); DE (12); CH (6)