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

NCT ID: NCT00323869

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2013-10-31

Brief Summary

A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).

Detailed Description

This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is 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 cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.

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.

Conditions

Lung Cancer; Non-small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab + carboplatin + gemcitabine

Bevacizumab in combination with carboplatin and gemcitabine:

•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.

Carboplatin was administered before the gemcitabine infusion:

•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles

Bevacizumab was administered 1 hour after end of all chemotherapy infusions:

•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody

Gemcitabine

Intervention Type: DRUG

Nucleoside analog

Carboplatin

Intervention Type: DRUG

Alkylating agent

Interventions

Bevacizumab

Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody

Intervention Type: DRUG

Gemcitabine

Nucleoside analog

Intervention Type: DRUG

Carboplatin

Alkylating agent

Intervention Type: DRUG

Other Intervention Names

Avastin; C225; rhuMAb-VEGF; Gemzar; Paraplatin; CBDCA

Eligibility Criteria

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 4, 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
• 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
• 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
• 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
• Coagulopathy
• Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
• Pregnant
• 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 within 7 days prior to day 0
• Fine needle aspirations within 7 days prior to day 0
• Core biopsies within 7 days prior to day 0
• Urine protein: creatinine ratio ≥ 1.0 at screening
• History of abdominal fistula within 6 months prior to Day 0
• Gastrointestinal perforation within 6 months prior to Day 0
• Intra-abdominal abscess within 6 months prior to Day 0
• Serious, non-healing wound
• Ulcer
• Bone fracture
• Lung carcinoma of squamous cell histology
• Any histology in close proximity to a major vessel
• 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 2 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Heather Wakelee

Associate Professor of Medicine (Oncology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather A Wakelee, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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, United States

Countries

United States

References

Clement-Duchene 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 cell lung cancer. J Thorac Oncol. 2010 Nov;5(11):1821-5. doi: 10.1097/JTO.0b013e3181f1d23c.

Reference Type: RESULT

PMID: 20881641 (View on PubMed)

Other Identifiers

96655

Identifier Type: OTHER

Identifier Source: secondary_id

AVF3576s

Identifier Type: -

Identifier Source: secondary_id

LUN0013

Identifier Type: OTHER

Identifier Source: secondary_id

NCT00323869

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-03730

Identifier Type: -

Identifier Source: org_study_id