Status:
COMPLETED
Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Extensive Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 use...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to six month progression free survival in patients with previously untreated SCLC. II...
Eligibility Criteria
Inclusion
- 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 =\< 1.5 mg
- Total bilirubin =\< 1.5 mg
- Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk; all females of childbearing potential must have a blood test or urine study within 2 weeks, prior to registration to rule out pregnancy
- Women of childbearing potential and sexually active males are strongly advised to use an effective method of contraception
- Patients must be disease-free for \> 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 =\< 1 gm of protein in 24 hours to allow participation in the study; NOTE: Urinalysis is also acceptable
- Patients must have INR =\< 1.5 and a PTT no greater than the institutional upper limit of normal within 1 week prior to registration
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not have history of thrombotic or hemorrhagic disorders; patients must not have recently (within 6 months of registration) experienced arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI); patients must also not have clinically significant peripheral artery disease
- Patients with history of hypertension must be well-controlled (=\< 150/85) on a stable regimen of anti-hypertensive therapy
- Patients must not be receiving chronic daily treatment with aspirin (\> 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00079040
Start Date
January 1 2006
End Date
January 1 2009
Last Update
May 14 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215