A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Chemotherapy
- Conditions
- Small Cell Lung Cancer
- Sponsor
- Genentech, Inc.
- Enrollment
- 102
- Primary Endpoint
- Progression-free Survival (PFS)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
- •Measurable disease or lesions
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria
- •Life expectancy of \< 12 weeks
- •Current, recent, or planned participation in another experimental drug study
- •Ongoing or active infection
- •Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years
- •Prior systemic therapy, radiation therapy, or surgery for SCLC
- •Inadequate bone marrow function, renal function, or hepatic function
- •Serum sodium of \< 120 mg/dL
- •Inadequately controlled hypertension
- •History of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association Class II or greater congestive heart failure
Arms & Interventions
Placebo+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide
Intervention: Chemotherapy
Placebo+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide
Intervention: Placebo
Bevacizumab+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide
Intervention: Bevacizumab
Bevacizumab+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide
Intervention: Chemotherapy
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: Randomization until progression or lost to follow-up (up to 2 years)
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Secondary Outcomes
- Overall Survival(Randomization until death or lost of follow-up (up to 27 months))
- Percentage of Participants With an Objective Response(Randomization until progression or lost to follow-up (up to 2 years))
- Number of Participants With an Objective Response(Randomization until progression or lost to follow-up (up to 2 years))
- Duration of Objective Response(Randomization until progression or lost to follow-up (up to 2 years))