FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
Completed · Phase 2
Conditions studied: Non-Small Cell Lung Carcinoma
In brief
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 study is to determine the optimal interval between SGN-15 and docetaxel using FDG-PET imaging as a surrogate marker of response. In addition, clinical response rate, duration of response, and survival data will be collected.
Key facts
- Study ID
- NCT00086333
- Run by
- Seagen Inc.
- People needed
- 30
- Starts
- 2004-07-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2011-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- -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
Where it is running
- University of Chicago — Chicago, Illinois, United States
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
- Providence Health System, Regional Cancer Program — Portland, Oregon, United States
- Kaiser Permanente — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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