Phase 2
N=50
Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer
Recurrent Small-cell Lung Cancer (SCLC) · Lung Cancer, Small Cell
Bottom Line
View on ClinicalTrials.gov: NCT00698516 ↗Enrolled (actual)
50
Serious AEs
36.0%
Results posted
Feb 2011
Primary outcome: Primary: Percentage of Participants With Progression-free Survival (PFS) at 3 Months — 65 percentageof participants — p=0.017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-free Survival (PFS) at 3 Months |
65 | 0.017 sig |
| SECONDARY PFS - Overall |
12.64; 27.14; 17.43 | — |
| SECONDARY Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) |
0; 0; 0; 2; 6; 8 | — |
| SECONDARY Number of Participants With a Tumor Response (CR and PR) |
2; 6; 8 | — |
| SECONDARY Duration of Tumor Response (CR and PR) |
20.6 | — |
| SECONDARY Time to Tumor Response (CR and PR) |
5.8 | — |
| SECONDARY Overall Survival |
26.4; 37.0; 32.0 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT00698516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.