Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086333
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2004-06-30
Brief Title:
FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
Sponsor:
Seagen Inc
Organization:
Seagen Inc
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 02 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 andor 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 02 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 andor 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None