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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

SG015-0005

NCT ID:

NCT00086333

Start Date:

July 2004

Completion Date:

December 2005

Related Keywords:

  • Non-Small Cell Lung Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Taxotere
  • docetaxel
  • taxanes
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231
Kaiser PermanentePortland, Oregon  97227
Providence Health System, Regional Cancer ProgramPortland, Oregon  97213