NCT00434226

Brief Summary

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).

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 21, 2009

Completed
Last Updated

August 21, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

February 11, 2007

Results QC Date

July 9, 2009

Last Update Submit

July 9, 2009

Conditions

Non-Small Cell Lung Cancer

Keywords

SABER-LNSCLCAvastinSutent

Outcome Measures

Primary Outcomes (1)

  • Best Response

    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 Outcomes (4)

  • Serious Adverse Events

    60 days following the last administration of study treatment

  • Incidence of Grade ≥ 3 Adverse Events

    60 days following the last administration of study treatment

  • Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction

    60 days following the last administration of study treatment

  • Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption

    60 days following the last administration of study treatment

Study Arms (2)

Bevacizumab + Carboplatin/Paclitaxel + Sunitinib

EXPERIMENTAL
Drug: bevacizumabDrug: sunitinibDrug: carboplatinDrug: paclitaxel

Bevacizumab + Carboplatin/Paclitaxel

PLACEBO COMPARATOR
Drug: bevacizumabDrug: carboplatinDrug: paclitaxel

Interventions

bevacizumabDRUG

Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle

Bevacizumab + Carboplatin/PaclitaxelBevacizumab + Carboplatin/Paclitaxel + Sunitinib
sunitinibDRUG

25 mg/day for 2 weeks, followed by 1 week of rest

Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
carboplatinDRUG

On the first day of each cycle for 4 cycles

Bevacizumab + Carboplatin/PaclitaxelBevacizumab + Carboplatin/Paclitaxel + Sunitinib
paclitaxelDRUG

On the first day of each cycle for 4 cycles

Bevacizumab + Carboplatin/PaclitaxelBevacizumab + Carboplatin/Paclitaxel + Sunitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BevacizumabSunitinibCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Limitations and Caveats

Based on the early safety results from this study, Genentech halted further recruitment and discontinued treatment. Insufficient efficacy data was available to perform additional analyses and limited the interpretation of the analyses performed.

Results Point of Contact

Title
Medical Communications Specialist
Organization
Genentech, Inc.
800-821-8590

Study Officials

  • Julie Hambleton, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 11, 2007

First Posted

February 13, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Last Updated

August 21, 2009

Results First Posted

August 21, 2009

Record last verified: 2009-07