Non-Small Cell Lung CancerPhase 1/2NCT00216203
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
A Phase 1/2 study testing Pemetrexed and Cetuximab in people with Non-Small Cell Lung Cancer, run by Nasser Hanna, M.D. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Pemetrexed and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2005to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Texas Oncology Cancer Center
Austin, Texas, 78731
Greenebaum Cancer Center
Baltimore, Maryland, 21201
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Elkhart Clinic
Elkhart, Indiana, 46515
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Medical Consultants, P.C.
Muncie, Indiana, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
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
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.
Read the 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
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pemetrexed, Cetuximab
- Keywords
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
CetuximabDrug
Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment | Experimental | Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer. Receives: Drug: Pemetrexed; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 Months
Secondary outcomes (3)
Median Survival Time
Measured: 24 Months
Toxicity and Safety Profile
Measured: 12 months
Clinical Benefit Rate
Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Hanna, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb, Walther Cancer Institute
- Responsible party
- Sponsor-investigator, Nasser Hanna, M.D., Hoosier Cancer Research Network
- Investigators
- Nasser Hanna, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216203
- Sponsor's protocol ID
- HOG LUN04-79
- Status last verified
- Aug 2016
- First submitted
- 12 Sep 2005
- Last updated
- 29 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19701110
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00216203
- Acronym / sponsor ID
- HOG LUN04-79
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nasser Hanna, M.D.University, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb, Walther Cancer Institute
- Study start
- May 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 2 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment | Experimental | Drug: Pemetrexed, Drug: CetuximabPemetrexed + cetuximab for patients with recurrent non-small cell lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedPemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles | Drug | Investigational Treatment |
| CetuximabCetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle | Drug | Investigational Treatment |
Primary outcome
Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
Time frame: 12 months
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 To Progression (TTP)
Time frame: 24 Months
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
3 secondary outcomes
Median Survival Time
Time frame: 24 Months
Toxicity and Safety Profile
Time frame: 12 months
Clinical Benefit Rate
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19701110Jalal 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.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Hanna, M.D. study chair
Hoosier Oncology Group, LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pemetrexed and Cetuximab in people with Non-Small Cell Lung Cancer, run by Nasser Hanna, M.D. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00216203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.