Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer
This study has been completed.
Sponsor:
ImClone LLC
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00063388
First received: June 25, 2003
Last updated: April 8, 2010
Last verified: April 2010
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Purpose
Determine tumor response rate and time to disease progression, survival and safety in total populations.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer |
Biological: Cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC) |
Resource links provided by NLM:
Further study details as provided by ImClone LLC:
Primary Outcome Measures:
- The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the tumor response rate in the total population and in EGFR- subjects [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Time to disease progression in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Survival in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Safety in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 66 |
| Study Start Date: | May 2003 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
|
Biological: Cetuximab
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
Other Name: Erbitux
|
Detailed Description:
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
- Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
- Unidimensionally measurable NSCLC
- Subjects with tumor tissue available for EGFR assessment
- ECOG performance status of 0 or 1
- Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids
Exclusion Criteria
- Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
- Women of childbearing potential using a prohibited contraceptive method
- Women who were pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063388
Locations
| United States, Florida | |
| ImClone Investigational Site | |
| Aventura, Florida, United States, 33180 | |
| ImClone Investigational Site | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| ImClone Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| ImClone Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| ImClone Investigational Site | |
| South Bend, Indiana, United States, 46601 | |
| United States, Massachusetts | |
| ImClone Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| ImClone Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| ImClone Investigational Site | |
| Saint Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
| Study Chair: | E-mail: ClinicalTrials@ ImClone.com | ImClone LLC |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00063388 History of Changes |
| Other Study ID Numbers: | CA225-012 |
| Study First Received: | June 25, 2003 |
| Last Updated: | April 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ImClone LLC:
|
Non Small Cell Lung Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013