Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer

NCT ID: NCT00698516

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-05-31

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.

Conditions

Recurrent Small-cell Lung Cancer (SCLC); Lung Cancer, Small Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label, Single arm

Oral topotecan + IV Bevacizumab

Group Type: EXPERIMENTAL

Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)

Intervention Type: DRUG

2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.

Interventions

Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)

2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Naples, Florida, United States

GSK Investigational Site

Athens, Georgia, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Jackson, Mississippi, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

GSK Investigational Site

Chattanooga, Tennessee, United States

GSK Investigational Site

Memphis, Tennessee, United States

GSK Investigational Site

Memphis, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23391616 (View on PubMed)

Other Identifiers

104864/111127

Identifier Type: -

Identifier Source: org_study_id