Non-Small Cell Lung CancerPhase 2NCT00732303
Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer
A Phase 2 study testing Pemetrexed and Radiation Therapy in people with Non-Small Cell Lung Cancer, run by Hoosier Cancer Research Network at 18 sites in United States.
Trial summary
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC. 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 Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 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
- Histological or cytological proof of Non Small Cell Lung Cancer (NSCLC)
- Measurable or non-measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy
- Unresectable Stage IIIA or IIIB disease as evaluated by imaging within 28 days prior to registration for protocol therapy
- Weight loss of greater than 10% in the preceding six months prior to registration for protocol therapy.
- Serum albumin < 0.85 x institutional lower limit of normal
- Able and willing to interrupt non-steroidal anti-inflammatory agents for 2 days before (5 days for long acting agents such as piroxicam), the day of, and 2 days following administration of pemetrexed
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- Lung V20 < 35% within 14 days prior to registration for protocol therapy, as planned by the radiation oncologist
- Mean lung dose < 20 Gy within 14 days prior to registration for protocol therapy, as planned by the radiation oncologist
- Written informed consent and HIPAA authorization for release of personal health information
- Age ≥ 18 years
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 90 days following completion of study treatment.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
Who cannot join
- Patients with malignant pleural effusions are not eligible. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.• No CNS metastases. All patients must undergo a CT scan/MRI of the brain within 28 days prior to registration for protocol therapy to exclude brain metastasis.
- No prior chemotherapy, adjuvant therapy or radiotherapy for lung cancer.
- No metastatic disease as determined by PET scan within 28 days prior to registration for protocol therapy.
- No active clinically serious infections as judged by the treating investigator (> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- No other active malignancies.
- No history of collagen vascular disease (CVD).
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- No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
- No history of psychiatric illness/social situations that would limit compliance with study requirements.
- Females must not be breastfeeding.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
NorthShore University Health System - Kellogg Cancer Center
Evanston, Illinois, 60201
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
IN Onc/Hem Associates
Indianapolis, Indiana, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Community Regional Cancer Center
Indianapolis, Indiana, 46256
Horizon Oncology Center
Lafayette, Indiana, 47905
Hematology Oncology Associates S.J., P.A.
Mount Holly, New Jersey, 08060
Medical Consultants, P.C.
Muncie, Indiana, 47303
Monroe Medical Associates
Munster, Indiana, 46321
Pennsylvania Oncology-Hematology Associates
Philadelphia, Pennsylvania, 19106
Providence Portland Medical Center
Portland, Oregon, 97213
Fox Chase Cancer Center Extramural Research Program
Rockledge, Pennsylvania, 19046
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Siteman Cancer Center
St Louis, Missouri, 63110
Providence Medical Group
Terre Haute, Indiana, 47802
About this study
Official title: A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.
Read the detailed description
OUTLINE: This is a multi-center study.
- Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
- Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Performance Status: ECOG performance status 2
Life Expectancy: Not specified
Hematopoietic:
- Platelets ≥ 100 K/mm3
- Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN.
- Alanine transaminase (ALT) ≤ 2.5 x ULN.
- Total bilirubin ≤ 1.5 x ULN
Renal:
- Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
Cardiovascular:
- No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
Pulmonary:
- Forced expiratory volume in 1 second (FEV1) greater than 1L
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pemetrexed, Radiation Therapy
- 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 (Alimta) 500mg/^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation TherapyRadiation
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks. Receives: Drug: Pemetrexed; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation
Measured: 24 months
Secondary outcomes (2)
Assess Safety and Toxicity
- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
Measured: 24 months
Overall Survival
To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Study terminated due to withdrawal of pharmaceutical funding
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Nasser Hanna, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732303
- Sponsor's protocol ID
- LUN08-129
- Status last verified
- Mar 2016
- First submitted
- 7 Aug 2008
- Last updated
- 27 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129
- ClinicalTrials.gov ID
- NCT00732303
- Acronym / sponsor ID
- LUN08-129
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to withdrawal of pharmaceutical funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 27 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.
Detailed description
OUTLINE: This is a multi-center study.
- Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
- Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Performance Status: ECOG performance status 2
Life Expectancy: Not specified
Hematopoietic:
- Platelets ≥ 100 K/mm3
- Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN.
- Alanine transaminase (ALT) ≤ 2.5 x ULN.
- Total bilirubin ≤ 1.5 x ULN
Renal:
- Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
Cardiovascular:
- No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
Pulmonary:
- Forced expiratory volume in 1 second (FEV1) greater than 1L
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pemetrexed, Radiation: Radiation Therapy* Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles * Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday. The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological or cytological proof of Non Small Cell Lung Cancer (NSCLC)
- Measurable or non-measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy
- Unresectable Stage IIIA or IIIB disease as evaluated by imaging within 28 days prior to registration for protocol therapy
- Weight loss of greater than 10% in the preceding six months prior to registration for protocol therapy.
- Serum albumin < 0.85 x institutional lower limit of normal
Key exclusion criteria (9 listed)
- Patients with malignant pleural effusions are not eligible. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.• No CNS metastases. All patients must undergo a CT scan/MRI of the brain within 28 days prior to registration for protocol therapy to exclude brain metastasis.
- No prior chemotherapy, adjuvant therapy or radiotherapy for lung cancer.
- No metastatic disease as determined by PET scan within 28 days prior to registration for protocol therapy.
- No active clinically serious infections as judged by the treating investigator (> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- No other active malignancies.
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 (Alimta) 500mg/^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles | Drug | 1 |
| Radiation TherapyRadiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday. The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks. | Radiation | 1 |
Primary outcome
Progression Free Survival
Time frame: 24 months
To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation
2 secondary outcomes
Assess Safety and Toxicity
Time frame: 24 months
Overall Survival
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Cancer Research Network
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed and Radiation Therapy in people with Non-Small Cell Lung Cancer, run by Hoosier Cancer Research Network at 18 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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 phase mean?
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 27 Apr 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?
Progression Free Survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2016.