Clinical trial NCT00698516: Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer
Official title: An Open-label, Multicenter, Non-comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-line Treatment in Subjects With Relapsed Small-cell Lung Cancer (SCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Small-cell Lung Cancer (SCLC)
Lung Cancer, Small Cell
Keywords: Bevacizumab
Small Cell Lung Cancer (SCLC)
Topotecan
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of SCLC.
* First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial diagnosis.
* Relapsed SCLC of any duration (both sensitive and resistant relapse).
* ECOG performance status of \</= 2.
* Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.
* No prior therapy with bevacizumab or any other VEGF inhibitor or topotecan

Exclusion Criteria:

* Uncontrolled emesis, regardless of etiology.
* Active uncontrolled infection.
* GI conditions or drugs that could impact absorption of oral topotecan.
* Known hypersensitivity to any component of topotecan capsule or compounds chemically related to topotecan.
* Uncontrolled hypertension with BP\>150/100.
* Prior h/o hypertensive crisis or encephalopathy.
* NYHA Grade II or greater congestive heart failure.
* H/O myocardial infarction within 6 months.
* H/O stroke or TIA within 6 months.
* H/O thrombotic or hemorrhagic disorders.
* Clinically significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.
* Anticipation of need for major surgical procedure during the study.
* Minor surgical procedures within 7 days prior to treatment start (placement of vascular access devices is permitted).
* H/O abdominal fistula, GI perforation, or intra-abdominal abscess within prior 6 months. Serious, non-healing wound, active ulcer, or untreated bone fracture. - H/O hemoptysis within prior 1 month.
* Concurrent radiotherapy.
* H/O whole lung radiation within 90 days prior to start of treatment.
* Presence or h/o central nervous system or brain metastases.
* H/o another malignancy other than SCLC.
* Concurrent chemotherapy, immunotherapy, or investigational therapy for the treatment of small cell lung cancer.

Primary outcomes:
measure: Percentage of Participants With Progression-free Survival (PFS) at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: PFS - Overall
timeFrame: Baseline to disease progression or death (up to 82.4 weeks)
measure: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
timeFrame: Baseline to disease progression or death (up to 82.4 weeks)
measure: Number of Participants With a Tumor Response (CR and PR)
timeFrame: Baseline to disease progression or death (up to 82.4 weeks)
measure: Duration of Tumor Response (CR and PR)
timeFrame: Baseline to disease progression or death (up to 82.4 weeks)
measure: Time to Tumor Response (CR and PR)
timeFrame: Baseline to disease progression or death (up to 82.4 weeks)
measure: Overall Survival
timeFrame: Baseline to disease progression or death (up to 82.4 weeks)
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Naples
country: United States
facility: GSK Investigational Site
state: Florida
city: Athens
country: United States
facility: GSK Investigational Site
state: Georgia
city: Macon
country: United States
facility: GSK Investigational Site
state: Georgia
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Mt. Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Spigel DR, Waterhouse DM, Lane S, Legenne P, Bhatt K. Efficacy and safety of oral topotecan and bevacizumab combination as second-line treatment for relapsed small-cell lung cancer: an open-label multicenter single-arm phase II study. Clin Lung Cancer. 2013 Jul;14(4):356-63. doi: 10.1016/j.cllc.2012.12.003. Epub 2013 Feb 4.