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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)

Phase 2
18 Years
Not Enrolling
Recurrent Small-cell Lung Cancer (SCLC), Lung Cancer, Small Cell

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Trial Information

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)

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of SCLC.

- First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial

- Relapsed SCLC of any duration (both sensitive and resistant relapse).

- ECOG performance status of
- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Progression-free Survival (PFS) at 3 Months

Outcome Description:

PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

May 2010

Related Keywords:

  • Recurrent Small-cell Lung Cancer (SCLC)
  • Lung Cancer, Small Cell
  • Bevacizumab
  • Small Cell Lung Cancer (SCLC)
  • Topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteSeattle, Washington  98133