FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
A Phase II Study Using FDG-PET to Investigate the Dosing Schedule and Response of Combination SGN-15 (cBR96-Doxorubicin Immunoconjugate) and Docetaxel in Patients With Stage IV or Stage IIIB Non-Small Cell Lung Carcinoma Ineligible for Combined Modality Treatment With Curative Intent
1 other identifier
interventional
30
1 country
4
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2004
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2004
CompletedStudy Start
First participant enrolled
July 1, 2004
CompletedFirst Posted
Study publicly available on registry
July 2, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedOctober 24, 2011
October 1, 2011
June 30, 2004
October 21, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (4)
University of Chicago
Chicago, Illinois, 60637, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Providence Health System, Regional Cancer Program
Portland, Oregon, 97213, United States
Kaiser Permanente
Portland, Oregon, 97227-1191, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2004
First Posted
July 2, 2004
Study Start
July 1, 2004
Study Completion
December 1, 2005
Last Updated
October 24, 2011
Record last verified: 2011-10