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

NCT00323869 | Completed Phase 2 Results DMC

• 5 other identifiers: IRB-0373096655AVF3576sLUN0013NCT00323869
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.

  18 months

Secondary Outcomes (8)

• Response Rate (CR + PR + SD)

  6 weeks

• Overall Survival (OS)

  36 months

• Partial Response (PR)

  6 weeks

• Complete Response (CR)

  6 weeks

• Stable Disease (SD)

  6 weeks

Study Arms (1)

Bevacizumab + carboplatin + gemcitabine

EXPERIMENTAL

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

Drug: Bevacizumab; Drug: Gemcitabine; Drug: Carboplatin

Interventions

Bevacizumab DRUG

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

Also known as: Avastin, C225, rhuMAb-VEGF

Bevacizumab + carboplatin + gemcitabine

Gemcitabine DRUG

Nucleoside analog

Also known as: Gemzar

Bevacizumab + carboplatin + gemcitabine

Carboplatin DRUG

Alkylating agent

Also known as: Paraplatin, CBDCA

Bevacizumab + carboplatin + gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Eli Lilly and Company: collaborator
• Genentech, Inc.: collaborator

Study Sites (3)

VA Palo Alto Healthcare System

Palo Alto, California, 94304-1290, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 20881641 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Cetuximab; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Heather A Wakelee, MD, Associate Professor of Medicine (Oncology)
• Organization: Stanford University Medical Center

hwakelee@stanford.edu

650-498-6000

Study Officials

• Heather A Wakelee, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Oncology)

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 7, 2016
• Results First Posted: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)