Clinical trial NCT00051571: Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Greenwich
country: United States
facility: Bendheim Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Portland
country: United States
facility: Providence Health System
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Seattle
country: United States
facility: Virginia Mason Research Center
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Andrew Sandler, MD
role: STUDY_DIRECTOR
References: