Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)
Overview
- Phase
- Phase 2
- Intervention
- Amrubicin
- Conditions
- Small Cell Lung Cancer
- Sponsor
- Celgene
- Enrollment
- 99
- Locations
- 25
- Primary Endpoint
- Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically/cytologically proven small cell lung cancer
- •Extensive disease
- •Measurable disease
- •World Health Organization (WHO) performance status 0-2
- •Age 18 years or older
- •Normal baseline cardiac function
- •No prior systemic chemotherapy for small cell lung cancer
- •Adequate organ function including bone marrow, kidney, and liver
- •No history of interstitial lung disease or pulmonary fibrosis
- •No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
Exclusion Criteria
- Not provided
Arms & Interventions
Amrubicin
Amrubicin 45mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Intervention: Amrubicin
Amrubicin plus Cisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> IV day 1 of each 21-day cycle until disease progression.
Intervention: Amrubicin
Amrubicin plus Cisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> IV day 1 of each 21-day cycle until disease progression.
Intervention: Cisplatin
Cisplatin plus etoposide
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 each 21-day cycle until disease progression.
Intervention: Cisplatin
Cisplatin plus etoposide
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 each 21-day cycle until disease progression.
Intervention: Etoposide
Outcomes
Primary Outcomes
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Time Frame: Until Disease Progression
Secondary Outcomes
- Toxicity(Until 30 days after last protocol treatment)
- Overall survival(Until death)
- Progression-free survival(Until disease progression or death)