Non-Small Cell Lung Cancer
Conditions
Brief 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.
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
Interventions
DRUGPemetrexed
Pemetrexed (Alimta) 500mg/\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
RADIATIONRadiation Therapy
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.
Sponsors
Eli Lilly and Company
Hoosier Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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.
Exclusion criteria
* 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 24 months | To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Safety and Toxicity | 24 months | \- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC. |
| Overall Survival | 24 months | To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Assignment * 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.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
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. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated | 2 |
Baseline characteristics
| Characteristic | Single Arm Assignment |
|---|---|
| Age, Continuous | 68.50 years |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 3 / 8 |
Outcome results
Primary
Progression Free Survival
To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation
Time frame: 24 months
Population: No data was collected and analyzed for this outcome measure due to termination of the study
Secondary
Assess Safety and Toxicity
\- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
Time frame: 24 months
Population: Most frequent toxicities reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Assignment | Assess Safety and Toxicity | Grade 1 and Grade 2 Fatigue | 7 participants |
| Single Arm Assignment | Assess Safety and Toxicity | Grade 1 and 2 Anorexia | 6 participants |
| Single Arm Assignment | Assess Safety and Toxicity | Grade 1 and 2 Cough | 6 participants |
| Single Arm Assignment | Assess Safety and Toxicity | Grade 3 and 4 Fatigue | 4 participants |
| Single Arm Assignment | Assess Safety and Toxicity | Grade 3 and 4 Anorexia | 3 participants |
| Single Arm Assignment | Assess Safety and Toxicity | Grade 3 and 4 Neutropenia | 3 participants |
Secondary
Overall Survival
To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
Time frame: 24 months
Population: No data was collected and analyzed for this outcome measure due to termination of the study.