Trial Outcomes & Findings for Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer (NCT NCT00732303)
NCT ID: NCT00732303
Last Updated: 2016-04-27
Results Overview
To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 months
Results posted on
2016-04-27
Participant Flow
Participant milestones
| Measure |
Single Arm Assignment
* Pemetrexed (Alimta) 500mg/m\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Arm Assignment
* Pemetrexed (Alimta) 500mg/m\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 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.
|
|---|---|
|
Overall Study
Study Terminated
|
2
|
Baseline Characteristics
Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Single Arm Assignment
n=8 Participants
* 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.
|
|---|---|
|
Age, Continuous
|
68.50 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: No data was collected and analyzed for this outcome measure due to termination of the study
To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Most frequent toxicities reported.
\- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
Outcome measures
| Measure |
Single Arm Assignment
n=8 Participants
* Pemetrexed (Alimta) 500mg/m\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 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.
|
|---|---|
|
Assess Safety and Toxicity
Grade 1 and Grade 2 Fatigue
|
7 participants
|
|
Assess Safety and Toxicity
Grade 1 and 2 Anorexia
|
6 participants
|
|
Assess Safety and Toxicity
Grade 1 and 2 Cough
|
6 participants
|
|
Assess Safety and Toxicity
Grade 3 and 4 Fatigue
|
4 participants
|
|
Assess Safety and Toxicity
Grade 3 and 4 Anorexia
|
3 participants
|
|
Assess Safety and Toxicity
Grade 3 and 4 Neutropenia
|
3 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: No data was collected and analyzed for this outcome measure due to termination of the study.
To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.
Outcome measures
Outcome data not reported
Adverse Events
Pemetrexed\Radiation
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed\Radiation
n=8 participants at risk
* 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.
|
|---|---|
|
Gastrointestinal disorders
ANOREXIA
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
DEHYDRATION
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
WEIGHT LOSS
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
Other adverse events
| Measure |
Pemetrexed\Radiation
n=8 participants at risk
* 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.
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
25.0%
2/8 • Number of events 9 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
ALKALINE PHOSPHATASE
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
ANOREXIA
|
75.0%
6/8 • Number of events 11 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
CONSTIPATION
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
75.0%
6/8 • Number of events 7 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
DEHYDRATION
|
25.0%
2/8 • Number of events 3 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
DIARRHEA
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Nervous system disorders
DIZZINESS
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
37.5%
3/8 • Number of events 5 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
75.0%
6/8 • Number of events 18 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
37.5%
3/8 • Number of events 4 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
75.0%
6/8 • Number of events 20 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
50.0%
4/8 • Number of events 7 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Cardiac disorders
HYPERTENSION
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Cardiac disorders
HYPOTENSION
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Infections and infestations
INFECTION
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
INSOMNIA
|
50.0%
4/8 • Number of events 5 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
25.0%
2/8 • Number of events 5 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
12.5%
1/8 • Number of events 7 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
37.5%
3/8 • Number of events 4 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
25.0%
2/8 • Number of events 3 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ESOPHAGUS
|
12.5%
1/8 • Number of events 3 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
4/8 • Number of events 8 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
25.0%
2/8 • Number of events 5 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
PAIN / BACK
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Cardiac disorders
PAIN / CARDIAC/HEART
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
PAIN - OTHER
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
25.0%
2/8 • Number of events 6 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / RADIATION
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Renal and urinary disorders
RENAL FAILURE
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
25.0%
2/8 • Number of events 5 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Gastrointestinal disorders
VOMITING
|
37.5%
3/8 • Number of events 6 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
|
General disorders
WEIGHT LOSS
|
25.0%
2/8 • Number of events 3 • Adverse event data was collected starting at baseline screening until participants went off treatment, which was a maximum of three cycles (months)
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place