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

This study has been completed.
Sponsor:
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00086333
First received: June 30, 2004
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Carcinoma
Drug: SGN-15, Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Estimated Enrollment: 30
Study Start Date: July 2004
Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086333

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Oregon
Kaiser Permanente
Portland, Oregon, United States, 97227-1191
Providence Health System, Regional Cancer Program
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Seattle Genetics, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00086333     History of Changes
Other Study ID Numbers: SG015-0005
Study First Received: June 30, 2004
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Carcinoma, Non-Small-Cell Lung
Taxotere
docetaxel
taxanes

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014