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

• ClinicalTrials.gov Identifier: NCT00660504
• Recruitment Status: Completed
• First Posted: April 17, 2008
• Results First Posted: July 4, 2014
• Last Update Posted: July 18, 2014
• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Information provided by (Responsible Party): Sumitomo Pharma (Suzhou) Co., Ltd.

Tracking Information

• First Submitted Date: April 10, 2008
• First Posted Date: April 17, 2008
• Results First Submitted Date: November 21, 2013
• Results First Posted Date: July 4, 2014
• Last Update Posted Date: July 18, 2014
• Study Start Date: April 2008
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2014): Overall Survival [ Time Frame: 1.5 years after last subject enrolled ]
• Original Primary Outcome Measures (submitted: April 10, 2008): Overall survival [ Time Frame: 1.5 years after last subject first visit ]

Current Secondary Outcome Measures (submitted: June 3, 2014)

• Progression-Free Survival [ Time Frame: 1.5 years after last subject enrolled ]
• 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.

• Original Secondary Outcome Measures (submitted: April 10, 2008): Progression-Free survival; Objective response rate; Toxicity [ Time Frame: 1.5 years after last subject first visit ]
• Current Other Pre-specified Outcome Measures (submitted: June 3, 2014): Overall Survival at 6 and 12 Months [ Time Frame: 6 and 12 months. ]
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
• Official Title: Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Cancer

Intervention

• Drug: Amrubicin Hydrochloride
  Amrubicin Hydrochloride combined with cisplatin
• Drug: Etoposide-Cisplatin combined chemotherapy
  combined chemotherapy

Study Arms

• Experimental: 1
  Amrubicin Hydrochloride-Cisplatin combined chemotherapy
  Intervention: Drug: Amrubicin Hydrochloride
• Active Comparator: 2
  Etoposide-Cisplatin combined chemotherapy
  Intervention: Drug: Etoposide-Cisplatin combined chemotherapy

• Publications *: Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 10, 2008): 300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00660504
• Other Study ID Numbers: D0750018; D0750018
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sumitomo Pharma (Suzhou) Co., Ltd.
• Original Responsible Party: Xiao-yan Lou, The medical department head of Sumiyaku China, Sumiyaku China Co., Ltd.
• Current Study Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yan Sun, MD; Cancer hospital, Chinese Academy of Medical Science

• PRS Account: Sumitomo Pharma (Suzhou) Co., Ltd.
• Verification Date: July 2014