Phase 2
N=189
S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer · Recurrent Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00828139 ↗Enrolled (actual)
189
Serious AEs
34.1%
Results posted
Apr 2016
Primary outcome: Primary: Progression-free Survival (PFS) — 1.8; 1.3; 1.4; 1.4 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ziv-aflibercept (Biological); topotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
1.8; 1.3; 1.4; 1.4 | — |
| SECONDARY Overall Survival |
6.0; 4.6; 4.6; 4.2 | — |
| SECONDARY Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) |
0.02; 0; 0.02; 0 | — |
| SECONDARY Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs |
1; 2; 3; 2; 1; 0 | — |
Summary
This randomized phase II trial is studying topotecan to see how well it works when given with or without aflibercept in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in aflibercept may be able to carry tumor-killing substances directly to small cell lung cancer cells. Aflibercept may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. It is not yet known whether topotecan is more effective with or without aflibercept in treating patients with small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed extensive stage small cell lung cancer
- Progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen (cisplatin or carboplatin)
- Measurable or non-measurable disease per RECIST criteria
- Disease must be outside a previously irradiated field OR a new lesion must be inside the irradiated field
- Disease must be outside a previously resected area OR a new lesion must be present
- No known brain metastasis unless the metastasis has been treated and is stable for ≥ 3 months prior to study entry
- No leptomeningeal involvement or brain stem metastasis
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60 mL/min
- Urine protein: creatinine ratio 150 mm Hg or diastolic BP > 100 mm Hg)
- History of hypertension allowed provided it is controlled on anti-hypertensive medications
- No history of congestive heart failure
- No history of encephalitis or encephalopathy of any cause
- No diverticulitis, gastrointestinal bleeding, or peptic ulcer within the past 3 months
- No known AIDS or HIV-1 associated complex
- No known history of immune or immunodeficiency disorders
- No unstable or pre-existing major medical conditions except for cancer-related abnormalities
- No other prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer currently in complete remission
- Any other cancer from which the patient been disease-free for 5 years
- Concurrent chronic therapeutic doses of low molecular weight heparin allowed
- At least 21 days since prior and no concurrent radiotherapy and recovered
- At least 28 days since prior and no concurrent surgery (e.g., thoracic or other major surgeries) and recovered
- No prior bevacizumab or other anti-angiogenic therapies including, but not limited to, small molecule tyrosine kinase inhibitors
- No concurrent enzyme-inducing anticonvulsant drugs
- Non-enzyme-inducing anticonvulsant drugs (e.g., Keppra) allowed
- Concurrent chronic oral anticoagulation therapy allowed provided INR is maintained in the therapeutic range (INR 2-3)
Data sourced from ClinicalTrials.gov (NCT00828139). 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.