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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGN-15
Docetaxel
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Medical Center
  • Bendheim Cancer Center
  • Florida Cancer Specialists
  • Hematology Oncology Associates of the Treasure Coast
  • University of Chicago
  • Providence Health System
  • Kaiser Permanente
  • Virginia Mason Research Center
  • Madigan Army Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 13, 2003
Last Updated
October 21, 2011
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00051571
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seagen Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SGN-15
Intervention Type
Drug
Intervention Name(s)
Docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sandler, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Bendheim Cancer Center
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Hematology Oncology Associates of the Treasure Coast
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Providence Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

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

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