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A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)
This study has been terminated.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00434226
  Purpose

This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab
Drug: sunitinib
Drug: carboplatin
Drug: paclitaxel
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Sunitinib Sunitinib malate Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title: 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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: First-line therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response and duration of response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or loss to follow-up ] [ Designated as safety issue: No ]
  • Serious and selected adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: March 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: sunitinib
Oral repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
2: Placebo Comparator Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434226

  Show 28 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Isaiah Dimery, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Isaiah Dimery, M.D., Study Director )
Study ID Numbers: AVF3996g
Study First Received: February 11, 2007
Last Updated: July 3, 2008
ClinicalTrials.gov Identifier: NCT00434226  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SABER-L
NSCLC
Avastin
Sutent

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Sunitinib
Paclitaxel
Lung Neoplasms
Lung Diseases
Carboplatin
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 13, 2009