Phase 2
N=65
Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00079040 ↗Enrolled (actual)
65
Serious AEs
76.6%
Results posted
Feb 2010
Primary outcome: Primary: Percentage of Participants Alive and Progression-free (PF) at 6 Months — 30.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); etoposide (Drug); bevacizumab (Biological); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Alive and Progression-free (PF) at 6 Months |
30.2 | — |
| SECONDARY Overall Survival |
10.9 | — |
| SECONDARY Best Objective Response |
40 | — |
Summary
This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.
Eligibility Criteria
Inclusion Criteria
- Histologic (or cytologic) proof of small cell lung cancer must be confirmed
- Patients must be clinically staged as extensive disease
- Patients must have measurable disease as defined by RECIST criteria; baseline scans/evaluation used to document measurable disease must be done within 4 weeks prior to registration; patients with measurable disease only or with both measurable and non-measurable disease are eligible
- Patients must have ECOG performance status of 0, 1, or 2
- Patients may not have had prior chemotherapy, immunotherapy, or biological therapy for lung cancer; previously irradiated lesions must not be the only site of measurable disease
- ANC > 1500/mm^3
- Platelets >= 100,000/mm^3
- Creatinine = 5 years if they have a history of prior malignancies (except for cured basal or squamous cell skin cancers, or carcinoma in situ of the cervix)
- Patients must be considered on psychosocial grounds to be willing and able to comply with the requirements of treatment and follow-up
- Patients must not have CNS metastases; a head CT is required within 4 weeks prior to study entry for evaluation (MRIs are also acceptable)
- Urine dipstick for proteinuria of less than 1+ is required within 7 days prior to study entry; if urine dipstick is >= 1+ then a 24 hour urine for protein must demonstrate = 325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is also not allowed
- Patients must not have serious non-healing wound, ulcer, or bone fracture, or major surgical procedure within 28 days prior to starting treatment; patients must not have had minor surgery or needle biopsies within 7 days of treatment
- Patients must not be on therapeutic anticoagulation
- Patients with a history of gross hemoptysis (defined as bright red blood of a 1/2 teaspoon or more) will be excluded from this trial
- Patients must have had no prior radiation therapy to the site of evaluable disease
Data sourced from ClinicalTrials.gov (NCT00079040). 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.