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.
(Based on data collected, the combination appeared to be poorly tolearated.)
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00434226
First received: February 11, 2007
Last updated: July 9, 2009
Last verified: July 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Best Response [ Time Frame: From randomization until disease progression/recurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serious Adverse Events [ Time Frame: 60 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Incidence of Grade ≥ 3 Adverse Events [ Time Frame: 60 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction [ Time Frame: 60 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption [ Time Frame: 60 days following the last administration of study treatment ] [ 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
Experimental: Bevacizumab + Carboplatin/Paclitaxel + Sunitinib Drug: bevacizumab
Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
Drug: sunitinib
25 mg/day for 2 weeks, followed by 1 week of rest
Drug: carboplatin
On the first day of each cycle for 4 cycles
Drug: paclitaxel
On the first day of each cycle for 4 cycles
Placebo Comparator: Bevacizumab + Carboplatin/Paclitaxel Drug: bevacizumab
Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
Drug: carboplatin
On the first day of each cycle for 4 cycles
Drug: paclitaxel
On the first day of each cycle for 4 cycles

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Genentech
Investigators
Study Director: Julie Hambleton, M.D. Genentech
  More Information

No publications provided

Responsible Party: Clincal Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00434226     History of Changes
Other Study ID Numbers: AVF3996g
Study First Received: February 11, 2007
Results First Received: July 9, 2009
Last Updated: July 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SABER-L
NSCLC
Avastin
Sutent

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Sunitinib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014