Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell)

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323869
• Other study ID #: IRB-03730
• Secondary ID: 96655AVF3576sLUN
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2006
• Last updated: April 21, 2015
• Start date: June 2006
• Est. completion date: October 2013

Study information

• Verified date: April 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

Open-label, phase 2, single-arm, multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).

Description:

This is a open-label, phase 2, single-arm, multi-center bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks, plus gemcitabine (1000 mg/m2 on day 1 and 8 every 3 weeks) and carboplatin (AUC of 5 every 3 weeks). Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment related toxicities. The primary outcome is progression-free survival (PFS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age 18 or higher

• Life expectancy of at least 3 months

• ECOG Performance status 0 to 1

• Advanced stage non-small cell lung cancer, NSCLC, Stage IIIB with malignant pleural effusion or Stage IV, excluding squamous cell histology, with measurable or evaluable disease

• No prior systemic therapy for advanced NSCLC (prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry)

• Palliative radiotherapy to painful bony metastases is permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression

• Willingness to use appropriate contraception to avoid pregnancy during the study (female patient or female partner of a male patient)

• Leukocytes = 3,000/µL

• Absolute neutrophil count = 1,500/ µL

• Platelets = 100,000/ µL

• Total bilirubin within normal institutional limits

• AST(SGOT)/ALT(SGPT) = 2.5 x institutional upper limit of normal

• Creatinine:

• Within normal institutional limits

• OR

• Creatinine clearance = 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

• Ability to sign informed consent

Exclusion Criteria:

• Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed at least 6 months prior to study entry)

• Known brain metastases

• Prior treatment with bevacizumab

• History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab

• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study

• Concomitant chemotherapy, radiotherapy, or investigational agents

• Evidence of bleeding diathesis or coagulopathy

• Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs

• Pregnant (positive pregnancy test) or lactating

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study

• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0

• Urine protein:creatinine ratio = 1.0 at screening

• History of abdominal fistula; gastrointestinal perforation; or intra-abdominal abscess within 6 months prior to Day 0

• Serious, non-healing wound, ulcer, or bone fracture

• Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist

• History of hemoptysis (bright red blood of 1/2 teaspoon or more)

• Blood pressure of > 150/100 mmHg

• Unstable angina

• New York Heart Association (NYHA) Grade II or greater congestive heart failure

• History of myocardial infarction within 6 months

• History of stroke within 6 months

• Clinically significant peripheral vascular disease

• Psychiatric illness/social situations that would limit compliance with study requirements

• Another active malignancy except for non-melanoma skin cancers

• Inability to comply with study and/or follow-up procedures

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Bevacizumab
Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
• Gemcitabine
Nucleoside analog
• Carboplatin
Alkylating agent

Locations

Country	Name	City	State
United States	VA Palo Alto Healthcare System	Palo Alto	California
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Clément-Duchêne C, Krupitskaya Y, Ganjoo K, Lavori P, McMillan A, Kumar A, Zhao G, Padda S, Zhou L, Pedro-Salcedo MS, Colevas AD, Wakelee HA. A phase II first-line study of gemcitabine, carboplatin, and bevacizumab in advanced stage nonsquamous non-small — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		every 6 weeks	No