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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00064012
First received: July 8, 2003
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: bortezomib
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Enrollment: 4
Study Start Date: May 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Velcade Alone
Velcade
Drug: bortezomib
Experimental: Velcade plus Docetaxel
Velcade plus Docetaxel
Drug: bortezomib Drug: docetaxel

Detailed Description:

OBJECTIVES:

Primary

  • Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel.

Secondary

  • Compare time to progression in patients treated with these regimens.
  • Compare the overall and 1-year survival of patients treated with these regimens.
  • Compare the safety and tolerability of these regimens in these patients.
  • Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
  • Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR.

Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment.

Patients are followed at 30 days and then every 3 months for survival.

PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064012

  Show 21 Study Locations
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joan H. Schiller, MD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00064012     History of Changes
Other Study ID Numbers: CDR0000305974, P30CA016042, WCCC-M34102-048, UCLA-0301037, MILLENNIUM-M34102-048
Study First Received: July 8, 2003
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014