Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT00086333
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2004-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
Sponsor:
Seagen Inc.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 carcinomas of the lung. SGN-15 induces its antitumor effect through binding to the cell surface LeY antigen. It is then rapidly internalized with release of doxorubicin inside the cell allowing the relative sparing of tissues normally affected by non-specific chemotherapy.
The study is open to patients with good performance status (ECOG 0\<=2) with stage IIIB or IV NSCLC which is not potentially curable by surgery or combined modality therapy and who have received no prior lung cancer chemotherapy for metastatic NSCLC.
Patients will be registered into one of two treatment sequences and wil receive SGN-15 and docetaxel in 4 week cycles consisting of treatment weekly for 3 weeks, followed by a week of rest.
Arm A will receive a combination os SGN-15 and docetaxel on the same day. Arm B will receive the combination of SGN-15 followed by the docetaxel 3 days later. All patients will undergo PET imaging prior to treatment and on Day 22.
Patients achieving a clinical response or stable disease as determined by physical examination and/or traditional restaging studies (using established RECIST criteria) after one 4 week cycle of therapy are eligible to receive continued cycles of SGN-15 and docetaxel on the same schedule until clinical or radiographic disease progression or toxicity occurs.
The study is open to patients with good performance status (ECOG 0\<=2) with stage IIIB or IV NSCLC which is not potentially curable by surgery or combined modality therapy and who have received no prior lung cancer chemotherapy for metastatic NSCLC.
Patients will be registered into one of two treatment sequences and wil receive SGN-15 and docetaxel in 4 week cycles consisting of treatment weekly for 3 weeks, followed by a week of rest.
Arm A will receive a combination os SGN-15 and docetaxel on the same day. Arm B will receive the combination of SGN-15 followed by the docetaxel 3 days later. All patients will undergo PET imaging prior to treatment and on Day 22.
Patients achieving a clinical response or stable disease as determined by physical examination and/or traditional restaging studies (using established RECIST criteria) after one 4 week cycle of therapy are eligible to receive continued cycles of SGN-15 and docetaxel on the same schedule until clinical or radiographic disease progression or toxicity occurs.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: