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Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: June 16, 2008   Last Updated: July 30, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00698516
  Purpose

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.


Condition Intervention Phase
Recurrent Small-cell Lung Cancer (SCLC)
Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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) [ Time Frame: One month following the last patient last visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate objective response rate, PFS, duration of response, time to response, and overall survival. [ Time Frame: One month following the last patient last visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open label, Single arm: Experimental
Oral topotecan + IV Bevacizumab
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698516

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 104864/111127
Study First Received: June 16, 2008
Last Updated: July 30, 2009
ClinicalTrials.gov Identifier: NCT00698516     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Small Cell Lung Cancer (SCLC)
Topotecan
Bevacizumab

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Bevacizumab
Angiogenesis Inhibitors
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Topotecan
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Bevacizumab
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Enzyme Inhibitors
Angiogenesis Inhibitors
Recurrence
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on August 28, 2009