CompletedPhase 2NCT00064012

Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Checked against the public recordLast updated Dec 13, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations21
SponsorUniversity of Wisconsin, Madison
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Wisconsin, Madison
Interventions being studied
Drug: bortezomib; 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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Locally advanced (stage IIIB) or metastatic (stage IV) disease * Inoperable disease * Relapsed or refractory disease * Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease * Measurable or evaluable disease * No symptomatic or inadequately treated brain metastases * No CNS disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic * AST and ALT less than 3 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine less than 1.8 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No electrocardiographic evidence of acute ischemia or active conduction system abnormalities * No poorly controlled hypertension Immunologic * No active systemic infection requiring treatment * No prior allergic reaction attributable to compounds containing boron or mannitol * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No peripheral neuropathy grade 2 or greater * No diabetes mellitus * No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 weeks since prior monoclonal antibody therapy * No concurrent routine use of colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * No prior docetaxel * Prior paclitaxel allowed * No other concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery * No concurrent surgery for cancer management or treatment Other * More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix * More than 4 weeks since prior investigational agents * No prior bortezomib * No other concurrent investigational agents * No other concurrent clinical research study participation * No other concurrent antineoplastic therapy * No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)

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

  • University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California
  • Jonsson Comprehensive Cancer Center, UCLALos Angeles, California
  • University of Colorado Cancer Center at University of Colorado Health Sciences CenterAurora, Colorado
  • Yale Comprehensive Cancer CenterNew Haven, Connecticut
  • University of Miami Sylvester Cancer CenterMiami, Florida
  • Winship Cancer Institute of Emory UniversityAtlanta, Georgia
  • Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia
  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts
  • Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota
  • Kansas City Cancer Centers - CentralKansas City, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 13, 2019. Always confirm current availability with the study team.

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