CompletedPhase 2NCT00541099
Official study title

Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Study summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedbevacizumab and docetaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 27, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Barbara Ann Karmanos Cancer Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Barbara Ann Karmanos Cancer Institute
Interventions being studied
Biological: bevacizumab; Drug: docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer
  • Stage III or IV disease
  • Stage III disease allowed, provided the patient is not a candidate for concurrent chemotherapy and radiotherapy
  • Mixed histology allowed, provided the biopsy has less than 50% squamous cell histology
  • Measurable or evaluable disease
Reasons someone may not be able to joinExclusion criteria
  • Squamous cell histology
  • Evidence of cavitation in the tumor
  • Tumors in close proximity to major blood vessels
  • No active, untreated brain metastases
  • More than 7 days since prior treatment for brain metastases AND no evidence of hemorrhage in the lesion
  • Stable or declining dose of steroids allowed PATIENT CHARACTERISTICS: Inclusion criteria:
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy \> 12 weeks
  • Leukocytes ≥ 3,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (\< 5 times ULN if patients has liver metastases)
  • Creatinine ≤ 1.5 times normal
  • Left ventricular function ≥ normal by MUGA scan or ECHO
  • Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis OR protein ≤ 1 g/24-hour urine collection
  • Fertile patients must use effective contraception and women should avoid breastfeeding

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
  • Nevada Cancer InstituteLas Vegas, Nevada
  • Case Comprehensive Cancer CenterCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 27, 2019. Always confirm current availability with the study team.

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