Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
This study has been completed.
Sponsor:
Hoosier Oncology Group
Collaborators:
Eli Lilly and Company
Bristol-Myers Squibb
ImClone LLC
Walther Cancer Institute
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT00216203
First received: September 12, 2005
Last updated: April 28, 2011
Last verified: April 2011
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Purpose
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Pemetrexed Drug: Cetuximab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79 |
Resource links provided by NLM:
Further study details as provided by Hoosier Oncology Group:
Primary Outcome Measures:
- The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- The primary objective of the phase II portion is to estimate the time to progression of this combination [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objectives of the phase II portion are to estimate the clinical benefit rate (CR + PR + SD lasting more than 90 days), median survival time and to further characterize the toxicity profile of this combination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 25 |
| Study Start Date: | May 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
|
Drug: Pemetrexed
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Drug: Cetuximab
Cetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle |
Detailed Description:
OUTLINE: This is a multi-center study.
Week 1 (day 1):
- Cetuximab 400mg/m2
Week 2 (Cycle 1, Day 1):
- Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.
Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.
Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles.
Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity
Performance status: ECOG 0-2
Life expectancy: At least 12 weeks
Hematopoietic:
- ANC > 1,500/mm3
- Platelets > 100,000/mm3
Hepatic:
- Bilirubin less than or equal to the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) < 1.5 X ULN. AST may be < 5 X ULN for patients with liver metastases
- Alkaline phosphatase < 5 X ULN
Renal:
- Calculated creatinine clearance > 45 mL/min (by Cockcroft-Gault)
Cardiovascular:
- No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)
Pulmonary:
- Not specified
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic or cytologic diagnosis of NSCLC
- Recurrent or metastatic disease that is not amenable to curative therapyMeasurable disease according to RECIST
- At least one prior platinum containing regimen for either locally advanced or metastatic disease
- Prior chemotherapy must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen
- Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period
- Prior radiation therapy allowed to < 25% of the bone marrow
- Negative pregnancy test
Exclusion Criteria:
- No active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
- No serious concomitant systemic disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 2 years.
- No major thoracic or abdominal surgery within 30 days prior to being registered for protocol therapy.
- No current breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216203
Locations
| United States, Illinois | |
| Medical & Surgical Specialists, LLC | |
| Galesburg, Illinois, United States, 61401 | |
| United States, Indiana | |
| Cancer Care Center of Southern Indiana | |
| Bloomington, Indiana, United States, 47403 | |
| Elkhart Clinic | |
| Elkhart, Indiana, United States, 46515 | |
| Fort Wayne Oncology & Hematology, Inc | |
| Fort Wayne, Indiana, United States, 46815 | |
| Center for Cancer Care at Goshen Health System | |
| Goshen, Indiana, United States, 46527 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Medical Consultants, P.C. | |
| Muncie, Indiana, United States, 47303 | |
| Northern Indiana Cancer Research Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Maryland | |
| Greenebaum Cancer Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Ohio | |
| Oncology Hematology Care, Inc. | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Texas | |
| Texas Oncology Cancer Center | |
| Austin, Texas, United States, 78731 | |
Sponsors and Collaborators
Hoosier Oncology Group
Eli Lilly and Company
Bristol-Myers Squibb
ImClone LLC
Walther Cancer Institute
Investigators
| Study Chair: | Nasser Hanna, M.D. | Hoosier Oncology Group, LLC |
More Information
Additional Information:
Publications:
| Responsible Party: | Nasser Hanna, M.D., Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00216203 History of Changes |
| Other Study ID Numbers: | HOG LUN04-79 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hoosier Oncology Group:
|
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 |
Pemetrexed Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013