Phase 3
N=78
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
Small Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00143455 ↗Enrolled (actual)
78
Serious AEs
18.1%
Results posted
Jan 2010
Primary outcome: Primary: Overall Survival (OS) for the Full Analysis Population (FAP) — 10.2177; 9.6591 months — p=0.0556
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Etoposide + cisplatin (Drug); Irinotecan + cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) for the Full Analysis Population (FAP) |
10.2177; 9.6591 | 0.0556 |
| PRIMARY Overall Survival for the Per Protocol (PP) Population |
10.5791; 9.4292 | 0.0110 sig |
| SECONDARY Number of Subjects With Overall Confirmed Response |
79; 94 | 0.143 |
| SECONDARY Duration of Response (DR) |
5.5195; 4.8953 | 0.0831 |
| SECONDARY Time to Tumor Progression (TTP) |
5.3552; 6.2423 | 0.7544 |
| SECONDARY European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) |
— | — |
| SECONDARY Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics) |
— | — |
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).
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).
Data sourced from ClinicalTrials.gov (NCT00143455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.