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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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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



- 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.


- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 3 months


- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 8.0 g/dL

- Absolute neutrophil count greater than 1,500/mm^3


- 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


- Creatinine less than 1.8 mg/dL


- 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

- No poorly controlled hypertension


- No active systemic infection requiring treatment

- No prior allergic reaction attributable to compounds containing boron or mannitol

- HIV negative


- 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


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


- 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


- More than 4 weeks since prior radiotherapy

- No concurrent radiotherapy


- More than 4 weeks since prior major surgery

- No concurrent surgery for cancer management or treatment


- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

July 2004

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Huntsman Cancer Institute Salt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
St. Louis University Hospital Cancer Center Saint Louis, Missouri  63110
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
University of Miami Sylvester Cancer Center Miami, Florida  33136
Siteman Cancer Center Saint Louis, Missouri  63110
Kansas City Cancer Centers - Central Kansas City, Missouri  64111