A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)

July 9, 2009 updated by: Genentech, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response
Time Frame: From randomization until disease progression/recurrence
The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
From randomization until disease progression/recurrence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: 60 days following the last administration of study treatment
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
60 days following the last administration of study treatment
Incidence of Grade ≥ 3 Adverse Events
Time Frame: 60 days following the last administration of study treatment
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Time Frame: 60 days following the last administration of study treatment
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Time Frame: 60 days following the last administration of study treatment
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
60 days following the last administration of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Julie Hambleton, M.D., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 11, 2007

First Submitted That Met QC Criteria

February 11, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

August 21, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVF3996g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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