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A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Signed Informed Consent Form

- Age ≥ 18 years

- Advanced histologically or cytologically confirmed NSCLC (Stage IIIb with malignant
pleural or pericardial effusion, Stage IV, or recurrent)

- Measurable or non-measurable disease

- Patients with treated brain metastases are eligible if there is no evidence of
progression or hemorrhage after treatment, as ascertained by clinical examination and
brain imaging (MRI or CT) during the screening period (brain imaging to be competed
Day -7 to Day 1).

- Prior treatment for CNS disease as deemed appropriate by the treating physician

- ECOG performance status 0 or 1

- Ability and willingness to comply with study and follow-up procedures

Exclusion Criteria:

- Prior systemic chemotherapy for metastatic disease

- Active malignancy other than lung cancer

- Current, recent, or planned participation in another experimental drug study

- Prior treatment with anti-VEGF agent or agents targeting similar pathways as
sunitinib

- Adjuvant chemotherapy or prior combined modality neoadjuvant therapy (chemotherapy
plus radiotherapy with or without surgery) within 6 months prior to Day 1 of Cycle 1

- Life expectancy of < 12 weeks

- Current, recent, or planned participation in an experimental drug study

- Inability to take oral medication or requirement of IV alimentation or total
parenteral nutrition, or prior surgical procedures affecting absorption

- Inadequate organ function

- Known evidence of disseminated intravascular coagulopathy

- Active infection or fever > 38.5°C within 3 days prior to Day 1 of Cycle 1

- Untreated abnormal thyroid function tests as defined by institutional standards
(patients with controlled hypothyroidism are eligible for study participation)

- Any other medical condition(s) (including mental illness or substance abuse) deemed
by the clinician to be likely to interfere with a patient's ability to provide
informed consent, cooperate, or participate in the study, or to interfere with the
interpretation of the results

- Intrathoracic lung carcinoma of squamous cell histology

- Known CNS disease except for treated brain metastases

- Inadequately controlled hypertension

- Prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Class II or greater CHF

- History of myocardial infarction or unstable angina within 12 months prior to Day 1
of Cycle 1

- History of stroke or transient ischemic attack within 12 months prior to Day 1 of
Cycle 1

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis within 6 months prior to Day 1 of Cycle 1

- History of hemoptysis within 1 month prior to Day 1 of Cycle 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 of Cycle 1 or anticipation of need for major surgical procedure during
the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1 of Cycle 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day 1 of Cycle 1

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Proteinuria at screening, as demonstrated by a urine protein/creatinine ratio of ≥
1.0 at screening

- Known hypersensitivity to any component of bevacizumab or sunitinib

- Pregnancy (positive pregnancy test) or lactation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Response

Outcome Time Frame:

From randomization until disease progression/recurrence

Safety Issue:

No

Principal Investigator

Julie Hambleton, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF3996g

NCT ID:

NCT00434226

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • SABER-L
  • NSCLC
  • Avastin
  • Sutent
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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