Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT00051571

Run by

Seagen Inc.

People needed

60

Expected to finish

2003-10-01

Last updated by the study team

2011-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or
• Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion
• 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)

You may not qualify if…

• Prior therapy with TAXOTERE (docetaxel)
• Cumulative anthracycline exposure > 300 mg/m2.
• More than one primary malignancy with the exception of:
• Non-melanoma skin cancer
• In situ carcinoma of the cervix
• Localized prostate cancer
• Completely resected stage I or II disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years.
• 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.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Bendheim Cancer Center — Greenwich, Connecticut, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Providence Health System — Portland, Oregon, United States
• Kaiser Permanente — Portland, Oregon, United States
• Virginia Mason Research Center — Seattle, Washington, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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