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A Randomized, Non-comparative, Multicenter, Open-Label, Phase 2 Study of Tarceva™ (Erlotinib) Alone and of Tarceva Plus VELCADE* (Bortezomib) for Injection in Patients With Relapsed or Refractory, Locally Advanced or Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
NSCLC

Thank you

Trial Information

A Randomized, Non-comparative, Multicenter, Open-Label, Phase 2 Study of Tarceva™ (Erlotinib) Alone and of Tarceva Plus VELCADE* (Bortezomib) for Injection in Patients With Relapsed or Refractory, Locally Advanced or Metastatic Non-Small Cell Lung Cancer


Inclusion Criteria:



1)Relapsed or refractory, Stage IIIB or Stage IV NSCLC that has been histologially or
cytologically confirmed. 2)One prior line of conventional cytotoxic chemotherapy.
3)Documented progressive disease(PD) during or since last prior therapy as determined by
the investigator. 4)18 y/o or older. 5)Have measurable disease by RECIST. 6)Eastern
Cooperative Oncology Group (ECOG) performance status 0 or 1. 7)Life expectancy greater
than 3 mo from the date of enrollment. 8)Female patient is either post-menopausal,
surgically sterilized or willing to use an acceptable method of birth control. 9)Male
pateint agrees to use an acceptable method of birth control during study treatment.
10)Provide written informed consent before the conduct of any study-related procedure.
11)Willing and able to comply with the protocol requirements.

Exclusion Criteria:

1)Previous treatment w/VELCADE. 2)Pre-existing interstitial lung disease. 3)Peripheral
neuropathy of Grade 2 or greater. 4)Diarrhea or vomiting greater than Grade 1 in intensity
whether in the absence or presence of antidiarrheal and/or antiemetic therapy.
5)Chemotherapy, radiation therapy, treatment wtih monoclonal Antibodies, or major surgery
w/in 4 wks prior to enrollment. 6)Documented greater than 10% WT loss in the 6 wks. prior
to enrollment. 7)Inadequate organ function during screening as per laboratory values.
8)Myocardial infarction w/in 6 months prior to enrollment. 9)Brain metastases. 10)Any
malignancy other than NSCLC occuring w/in 5 years of enrollment with the exception of
basal cell carcinoma of the sin, and carcinoma in situ of the cervix. 11)Hx of allergic
reaction to compounds containing boron or mannitol. 12)Known human immunodeficiency virus
(HIV)+ or hepatitis B. 13)Poorly controlled hypertension, diabetes mellitus, or
pyschiatric illness. 14)Pregnant or breast-feeding woman. Confirmation that patient is not
pregnant must be established by a negative serum (B-hCG).15)Currently enrolled in another
clinical research study or has received an investigational agent w/in 4 weeks prior to
enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

C05005

NCT ID:

NCT00283634

Start Date:

August 2005

Completion Date:

August 2007

Related Keywords:

  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of TenneseeKnoxville, Tennessee  37920