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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 16, 2008

Last Updated Date

June 16, 2008

Start Date ^†

July 2008

Current Primary Outcome Measures ^†

To evaluate three-month progression free survival (PFS) rate after therapy with combination of oral topotecan and bevacizumab in subjects with relapsed small-cell lung cancer (SCLC)

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

To evaluate objective response rate, PFS, duration of response, time to response, and overall survival.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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)

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Recurrent Small-Cell Lung Cancer (SCLC)

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Estimated Enrollment ^†

Completion Date

Primary Completion Date

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698516

Responsible Party

Secondary IDs ^††

111127

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Genentech

Investigators ^†

Study Director:

GSK Clinical Trial Call Center, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.