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

NCT ID: NCT00051571

Last Updated: 2011-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2003-10-31

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel

Intervention Type: DRUG

SGN-15

Intervention Type: DRUG

Eligibility Criteria

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:

• 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)

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Andrew Sandler, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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

Countries

United States

Other Identifiers

SG0002-015

Identifier Type: -

Identifier Source: org_study_id

NCT00031603

Identifier Type: -

Identifier Source: nct_alias