Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
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
1 other identifier
interventional
36
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer
Started May 2005
Typical duration for phase_1 nonsmall-cell-lung-cancer
11 active sites
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
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
June 2, 2016
CompletedSeptember 29, 2016
August 1, 2016
3.6 years
September 12, 2005
April 27, 2016
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
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
12 months
Time To Progression (TTP)
The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
24 Months
Secondary Outcomes (3)
Median Survival Time
24 Months
Toxicity and Safety Profile
12 months
Clinical Benefit Rate
12 months
Study Arms (1)
Investigational Treatment
EXPERIMENTALPemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Interventions
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nasser Hanna, M.D.lead
- Eli Lilly and Companycollaborator
- Bristol-Myers Squibbcollaborator
- Walther Cancer Institutecollaborator
Study Sites (11)
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403, United States
Elkhart Clinic
Elkhart, Indiana, 46515, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Related Publications (1)
Jalal S, Waterhouse D, Edelman MJ, Nattam S, Ansari R, Koneru K, Clark R, Richards A, Wu J, Yu M, Bottema B, White A, Hanna N. Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC): a phase I/II study from the Hoosier Oncology Group. J Thorac Oncol. 2009 Nov;4(11):1420-4. doi: 10.1097/JTO.0b013e3181b624ae.
PMID: 19701110RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Data Coordinator
- Organization
- Hoosier Cancer Research Network, Inc.
Study Officials
- STUDY CHAIR
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
May 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
September 29, 2016
Results First Posted
June 2, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share