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| Sponsored by: |
Seattle Genetics, Inc. |
|---|---|
| Information provided by: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00051571 |
Purpose
This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen.
Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: SGN-15 Drug: Docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study Using SGN-15 (cBR96-Doxorubicin Immunoconjugate) in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy.
Lewis-y antigen expression documented by immunohistochemistry for all patients.
Patients must have:
Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months
Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy)
EXCLUSION CRITERIA:
Prior therapy with TAXOTERE (docetaxel)
Cumulative anthracycline exposure > 300 mg/m2.
More than one primary malignancy with the exception of:
Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure).
Uncontrolled, symptomatic brain metastasis.
Peripheral neuropathy > grade 2.
Concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis.
Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B or C.
Women who are pregnant or breastfeeding
Any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins.
Dementia or altered mental status that would prohibit the understanding and rendering of informed consent.
Patients with uncontrolled peptic ulcer disease will be excluded.
Contacts and Locations| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Connecticut | |
| Bendheim Cancer Center | |
| Greenwich, Connecticut, United States, 06830 | |
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Hematology Oncology Associates of the Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Oregon | |
| Providence Health System | |
| Portland, Oregon, United States, 97213 | |
| Kaiser Permanente | |
| Portland, Oregon, United States, 97227 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Study Director: | Andrew Sandler, MD | Seattle Genetics, Inc. |
More Information
| Study ID Numbers: | SG0002-015 |
| Study First Received: | January 13, 2003 |
| Last Updated: | February 9, 2006 |
| ClinicalTrials.gov Identifier: | NCT00051571 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Carcinoma, Non-Small-Cell Lung |
|
Thoracic Neoplasms Immunologic Factors Recurrence Doxorubicin Carcinoma Docetaxel Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Immunoconjugates Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Immunoconjugates Neoplasms, Glandular and Epithelial |