Status:
COMPLETED
FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
Lead Sponsor:
Seagen Inc.
Conditions:
Non-Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The primary objective of the stu...
Detailed Description
SGN-15 is a mAb-drug immunoconjugate comprised of the chimeric anti-Lewis Y (LeY) mAb BR96, conjugated to doxorubicin. The LeY antigen is found as a glycoprotein at the cell surface on 90% of carcinom...
Eligibility Criteria
Inclusion
- Patients with pathologically confirmed stage IIIB or IV NSCLC with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent
- Patients must have an ECOG performance status of less than or equal to 2
- -Patients must have a tumor block available for documentation of LeY antigen expression by immunohistochemistry
- -FDG-PET imaging must be completed at a PET center approved by Seattle Genetics
- Patients must have adequate bone marrow and hepatic function
Exclusion
- -Prior cytotoxic therapy for metastatic NSCLC
- -Those with serious underlying non-malignant disease
- -Patients with peripheral neuropathy \> Grade 2 are excluded from study
- -Patients with IDDM or NIDDM
- Patients with known active viral, bacterial, or symptomatic fungal infection
- Concomitant with other antineoplastic or experimental agents
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00086333
Start Date
July 1 2004
End Date
December 1 2005
Last Update
October 24 2011
Active Locations (4)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
3
Providence Health System, Regional Cancer Program
Portland, Oregon, United States, 97213
4
Kaiser Permanente
Portland, Oregon, United States, 97227-1191