Last updated: 11/07/2018 00:49:34
Study of Oral Topotecan with Bevacizumab for Recurrent Small Cell Lung Cancer
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of participants with progression-free survival (PFS) at 3 months
Timeframe: 3 months
Secondary outcomes:
PFS - overall
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)
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)
Number of participants with a tumor response (CR and PR)
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)
Duration of tumor response (CR and PR)
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)
Time to tumor response (CR and PR)
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)
Overall survival
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)
Interventions:
Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2010-14-05
Time perspective:
Not applicable
Clinical publications:
D. Spigel, D. Waterhouse, S. Lane, P. Legenne, K. Bhatt. Efficacy and safety of oral topotecan and bevacizumab combination for use as second-line treatment of relapsed small-cell lung cancer: An open-label, multicenter, single-arm, Phase II study. Clin lung Cancer.
Medical condition
Recurrent small-cell lung cancer (SCLC)
Product
topotecan
Collaborators
Not applicable
Study date(s)
July 2008 to May 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Histologically or cytologically confirmed diagnosis of SCLC.
- First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial diagnosis.
- Uncontrolled emesis, regardless of etiology.
- Active uncontrolled infection.
Inclusion and exclusion 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
- 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.
Trial location(s)
Location
GSK Investigational Site
Seattle, Washington, United States, 98101-2795
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45236
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-14-05
Actual study completion date
2010-14-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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