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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer; Non-small Cell Lung Cancer (NSCLC)

Intervention: Bevacizumab (Drug); Gemcitabine (Drug); Carboplatin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Heather A Wakelee, MD, Principal Investigator, Affiliation: Stanford University


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).

Clinical Details

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)

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

Primary outcome: Progression-free survival (PFS)

Detailed 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).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Another active malignancy except for non-melanoma skin cancers

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

Locations and Contacts

VA Palo Alto Healthcare System, Palo Alto, California 94304-1290, United States

Santa Clara Valley Medical Center, San Jose, California 95128, United States

Stanford University School of Medicine, Stanford, California 94305, United States

Additional Information

Starting date: June 2006
Last updated: April 21, 2015

Page last updated: August 23, 2015

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