NCT00051571

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

October 24, 2011

Status Verified

October 1, 2011

First QC Date

January 13, 2003

Last Update Submit

October 21, 2011

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung

Interventions

SGN-15DRUG
DocetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Bendheim Cancer Center

Greenwich, Connecticut, 06830, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Providence Health System

Portland, Oregon, 97213, United States

Location

Kaiser Permanente

Portland, Oregon, 97227, United States

Location

Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Andrew Sandler, MD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2003

First Posted

January 15, 2003

Study Completion

October 1, 2003

Last Updated

October 24, 2011

Record last verified: 2011-10

Locations

US(9)