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Completed

NCT Number: NCT00660504

Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fuzhou, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically/cytologically proven small cell lung cancer
  • Extensive disease
  • No prior chemotherapy regimen
  • Age 18 years or older
  • ECOG performance status of 0-1

Exclusion criteria

  • Brain metastasis requiring treatment
  • Treatment (Surgical or radiotherapy)of primary tumor
  • Interstitial pneumonia or pulmonary fibrosis
  • Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

Treatment and study plan

amrubicin hydrochloride

Drug

Amrubicin Hydrochloride combined with cisplatin

Etoposide-Cisplatin combined chemotherapy

Drug

combined chemotherapy

Primary outcomes

  1. Overall Survival

    Time frame: 1.5 years after last subject enrolled

Secondary outcomes

  1. Progression-Free Survival

    Time frame: 1.5 years after last subject enrolled

  2. Objective Response Rate

    Time frame: participants were followed for the duration of the study, an average of 12 weeks

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Other outcomes

  1. Overall Survival at 6 and 12 Months

    Time frame: 6 and 12 months.

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2008
Registry last updated
Jul 18, 2014

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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