Trial Outcomes & Findings for Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer (NCT NCT00508144)
NCT ID: NCT00508144
Last Updated: 2017-02-13
Results Overview
Complete Response (CR): Complete disappearance of all measurable \& non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers \& other abnormal lab values. Partial Response (PR): Applies only to those with at least one measurable lesion. \>/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline. Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician. Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks
Results posted on
2017-02-13
Participant Flow
Recruitment Period: September 1, 2005 to June 30, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Of the 64 participants registered, fifty-eight (58) were eligible, four (4) were invaluable, and six (6) were not eligible to participate in this trial.
Participant milestones
| Measure |
Alimta
Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Alimta
Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.
|
|---|---|
|
Overall Study
Not eligible
|
6
|
|
Overall Study
Death
|
5
|
Baseline Characteristics
Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Alimta
n=64 Participants
Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Gender
Female
|
24 Participants
n=5 Participants
|
|
Gender
Male
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeksPopulation: Of 58 eligible participants, only 54 treated were available for response and five (5) experienced an early death, five (5) were later deemed inevaluable, and two had an indeterminate response.
Complete Response (CR): Complete disappearance of all measurable \& non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers \& other abnormal lab values. Partial Response (PR): Applies only to those with at least one measurable lesion. \>/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline. Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician. Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles).
Outcome measures
| Measure |
Alimta
n=42 Participants
Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.
|
|---|---|
|
Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)
|
3 Participants
|
Adverse Events
Alimta
Serious events: 32 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alimta
n=58 participants at risk
Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.
|
|---|---|
|
General disorders
Death
|
8.6%
5/58 • Number of events 5 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
ANEMIA
|
10.3%
6/58 • Number of events 6 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS EXACERBATION
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
CARDIOPULMONARY ARREST
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
General disorders
Chest Pain
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Vascular disorders
HYPOTENSION
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
ISCHEMIC ILEITIS/COLITIS
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Injury, poisoning and procedural complications
LEFT FEMUR FRACTURE
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
NEUTROPENIC FEVER
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
NONSUSTAINED VENTRICULAR TACHYCARDIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
13.8%
8/58 • Number of events 8 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
SEPTIC SHOCK
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
Other adverse events
| Measure |
Alimta
n=58 participants at risk
Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.
|
|---|---|
|
Investigations
Alkaline phosphatase increased
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Alanine aminotransferase decreased
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
ANEMIA
|
6.9%
4/58 • Number of events 4 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
8.6%
5/58 • Number of events 5 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
5/58 • Number of events 5 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Blood bilirubin increased
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
BRONCHITIS
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Reproductive system and breast disorders
CANDIDIASIS
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
CARDIOVASCULAR GENERAL
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
COLITIS
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
General disorders
CONSTITUTIONAL SYMPTOMS, FATIGUE
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Creatinine increased
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
DIARRHEA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Nervous system disorders
DIZZINESS
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
DRY MOUTH
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
13.8%
8/58 • Number of events 8 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
General disorders
EDEMA
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
General disorders
FATIGUE
|
17.2%
10/58 • Number of events 10 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
FEVER NEUTROPENIC
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
General disorders
FEVER UNKNOWN ORIGIN
|
12.1%
7/58 • Number of events 7 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
General disorders
FEVER WITHOUT NEUTROPENIA
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS (Belly pain)
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Hemoglobin increased
|
27.6%
16/58 • Number of events 16 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
10.3%
6/58 • Number of events 6 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
8.6%
5/58 • Number of events 5 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Vascular disorders
HYPOTENSION
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
INFECTION
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
INFECTION (OTHER)
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
INFECTION UNKNOWN
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
Infection with Normal White Blood Count
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
Infection with Normal Absolute Neutrophil Count (ANC)
|
8.6%
5/58 • Number of events 5 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Psychiatric disorders
INSOMNIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
MUCOSITIS (CLINICAL)
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
NAUSEA
|
15.5%
9/58 • Number of events 9 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Neutrophil count decreased
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
Platelet count decreased
|
8.6%
5/58 • Number of events 5 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY (OTHER)
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Renal and urinary disorders
RENAL/GENITOURINARY DISORDER
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Nervous system disorders
SENSORY ALTERATION
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
STOMATITIS
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
1.7%
1/58 • Number of events 1 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Investigations
WEIGHT LOSS
|
5.2%
3/58 • Number of events 3 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
|
Infections and infestations
WOUND INFECTION
|
3.4%
2/58 • Number of events 2 • Adverse event data collected for three-week treatment cycle, up to four cycles or 12 weeks.
|
Additional Information
Ralph Zinner, MD/Thoracic & Head and Neck Medicine
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place