NCT00021060

Brief Summary

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance

Trial Health

80
On Track

Trial Health Score

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

Enrollment
842

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 11, 2001

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

4.1 years

First QC Date

July 11, 2001

Last Update Submit

February 26, 2013

Conditions

Adenocarcinoma of the LungBronchoalveolar Cell Lung CancerLarge Cell Lung CancerRecurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Survival

    Analyses will be based on repeated confidence intervals for the hazard ratio, using O'Brien-Fleming stopping boundaries corresponding to a one-sided, 2.5% overall type I error. The confidence interval will be calculated on the log hazard ratio scale based on the log hazard ratio and variance estimates from the Cox partial likelihood, using the large sample normal approximation, and then the interval will be transformed to the hazard ratio scale.

    Up to 5 years

  • Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    After each episode, the two treatment arms will be compared with respect to these events using a Fisher's exact test with two sided p-value 0.05.

    Up to 5 years

Study Arms (2)

Arm I (paclitaxel and carboplatin)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: paclitaxelDrug: carboplatinOther: laboratory biomarker analysis

Arm II (paclitaxel, carboplatin, and bevacizumab)

EXPERIMENTAL

Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: paclitaxelDrug: carboplatinBiological: bevacizumabOther: laboratory biomarker analysis

Interventions

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Arm I (paclitaxel and carboplatin)Arm II (paclitaxel, carboplatin, and bevacizumab)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Arm I (paclitaxel and carboplatin)Arm II (paclitaxel, carboplatin, and bevacizumab)
bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Arm II (paclitaxel, carboplatin, and bevacizumab)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (paclitaxel and carboplatin)Arm II (paclitaxel, carboplatin, and bevacizumab)

Eligibility Criteria

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

You may qualify if:

  • Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma; mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible; cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
  • Patients must have advanced NSCLC (stage IIIB with malignant pleural effusion or stage IV or recurrent disease)
  • Patients must have measurable or non-measurable disease
  • ECOG performance status 0 or 1
  • Patients must not have known central nervous system (CNS) metastases; a head CT is required within 4 weeks prior to study entry; (MRIs are also acceptable)
  • Patients must not have received prior systemic chemotherapy at any time
  • ANC \>= 1500/mm\^3
  • Platelets \>= 100,000/mm\^3
  • Total bilirubin =\< 1.5 mg/dl
  • Transaminases =\< 5 x ULN
  • Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)
  • Urine dipstick for proteinuria of less than 1+ (i.e., either 0 or trace); if urine dipstick is \>= 1+ then a 24 hour urine for protein must demonstrate \< 500 mg of protein in 24 hours to allow participation in the study; note: urinalysis is also acceptable
  • Patients must have INR =\< 1.5 and a PTT no greater than upper limits of normal within 1 week prior to randomization
  • Pregnant and lactating women are excluded from the study
  • Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.

    PMID: 17167137DERIVED

MeSH Terms

Conditions

Adenocarcinoma of LungAdenocarcinoma, Bronchiolo-AlveolarCarcinoma, Non-Small-Cell Lung

Interventions

PaclitaxelTaxesCarboplatinBevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteCarcinoma, BronchogenicBronchial NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Alan Sandler

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

September 1, 2006

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)