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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051571
• Other study ID #: SG0002-015
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2003
• Last updated: October 21, 2011
• Est. completion date: October 2003

Study information

• Verified date: October 2011
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00031603

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• SGN-15

• Docetaxel

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States,