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NCT Number: NCT00349492

A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer

This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks

Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1.5 years

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soonchunhyang University Bucheon Hospital, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically diagnosed small cell lung cancer
  • Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)
  • If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
  • No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)
  • One or more measurable disease by RECIST criteria
  • at least 18 years of age
  • Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria
  • Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function
  • Informed consent from patient which conforms to Institutional Review Board

Exclusion criteria

  • History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years
  • Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
  • Uncontrolled serious infection
  • Enrollment in other study within 30 days

Treatment and study plan

IP

Drug

irinotecan+cisplatin

Other names: irinotecan + cisplatin

Primary outcomes

  1. Overall survival

    Time frame: month

Secondary outcomes

  1. Objective response rate

    Time frame: percent

  2. Progression free survival

    Time frame: month

  3. Safety profile

    Time frame: percent

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Sponsors and collaborators

Lead sponsor

Clinical Research Center for Solid Tumor, Korea

Other

Registry information

Official study title

Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Jul 7, 2006
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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