A Study of Tarceva for Use in Patients With Relapsed or Refractory Metastatic Non-Small Cell Lung Cancer

This study has been terminated.
(insufficient efficacy)
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00283634
First received: January 27, 2006
Last updated: February 16, 2011
Last verified: February 2011

January 27, 2006
February 16, 2011
August 2005
July 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00283634 on ClinicalTrials.gov Archive Site
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A Study of Tarceva for Use in Patients With Relapsed or Refractory Metastatic Non-Small Cell Lung Cancer
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

Tarceva, an orally available small molecule, has demonstrated potent activity in tumor models and humans. This randomized, open-label phase 2 study of Tarceva alone and of Tarceva plus VELCADE is designed primarily to determine the objective tumor response rates to these treatments in patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) that is refractory to or has relapsed after front-line chemotherapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
NSCLC
Drug: erlotinib and bortezomib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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August 2007
July 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283634
C05005
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Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Millennium Pharmaceuticals, Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP