FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• -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