Trial Outcomes & Findings for Pharmacogenomic & Phase II Study of Gemcitabine and Pemetrexed in Non-Small-Cell Lung Cancer. (NCT NCT00226577)
NCT ID: NCT00226577
Last Updated: 2017-03-23
Results Overview
Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan. Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of \>30% in the sum of the largest diameters of all measurable lesions and absence of new lesions.
COMPLETED
PHASE2
52 participants
06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
2017-03-23
Participant Flow
Participant milestones
| Measure |
Pre-Surgery Chemotherapy
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Overall Study
STARTED
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52
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Overall Study
COMPLETED
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52
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenomic & Phase II Study of Gemcitabine and Pemetrexed in Non-Small-Cell Lung Cancer.
Baseline characteristics by cohort
| Measure |
Pre-Surgery Chemotherapy
n=52 Participants
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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21 Participants
n=5 Participants
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Age, Categorical
>=65 years
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31 Participants
n=5 Participants
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Age, Continuous
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67 years
n=5 Participants
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Sex: Female, Male
Female
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26 Participants
n=5 Participants
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Sex: Female, Male
Male
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26 Participants
n=5 Participants
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Region of Enrollment
United States
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52 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006Population: A radiographic response evaluation was possible in 49 of 52 patients.
Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan. Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of \>30% in the sum of the largest diameters of all measurable lesions and absence of new lesions.
Outcome measures
| Measure |
Pre-Surgery Chemotherapy
n=49 Participants
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Disease Response - Radiographic
Complete Remission
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1 participants
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Disease Response - Radiographic
Partial Remission
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16 participants
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SECONDARY outcome
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006Population: A pathologic response evaluation was possible in 43 of 52 patients.
Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen, which consists of equal to or more than 95% fibrosis and necrosis.
Outcome measures
| Measure |
Pre-Surgery Chemotherapy
n=43 Participants
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Disease Response - Pathologic
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13 participants
Interval 13.0 to 43.0
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SECONDARY outcome
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006Population: 40 patients with complete tumor resection.
Disease-free survival (DFS) is defined as the period of time from surgery to the time when disease recurrence is clearly documented. A histologic confirmation is required in equivalent cases.
Outcome measures
| Measure |
Pre-Surgery Chemotherapy
n=40 Participants
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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Survival - Disease Free
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33.7 months
Interval 2.9 to 45.2
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SECONDARY outcome
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006Population: All patients
Median range of number of participants with Overall Survival. Overall survival (OS) will be defined as the period of time from the first day of drug treatment to the date of death of the patient. Patients taken off study will be followed quarterly until death for survival data.
Outcome measures
| Measure |
Pre-Surgery Chemotherapy
n=52 Participants
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Survival - Overall
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27.8 months
Interval 3.8 to 48.6
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SECONDARY outcome
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006Population: A total of 52 eligible patients, 26 men and 26 women, between the ages of 41 and 83 years received at least one dose of chemotherapy. Only 49 patients were evaluable because 3 patients had only the first cycle.
Number of participants with toxicity ≥ Grade 3 after gemcitabine plus pemetrexed induction chemotherapy.
Outcome measures
| Measure |
Pre-Surgery Chemotherapy
n=49 Participants
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Toxicity
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18 participants
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Adverse Events
Pre-Surgery Chemotherapy
Serious adverse events
| Measure |
Pre-Surgery Chemotherapy
n=52 participants at risk
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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Metabolism and nutrition disorders
Alanine Aminotransferase (ALT) - Grade 3
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5.8%
3/52 • Number of events 3 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Metabolism and nutrition disorders
Aspartate Aminotransferase (AST) - Grade 3
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1.9%
1/52 • Number of events 1 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Metabolism and nutrition disorders
Bicarbonate, serum low - Grade 4
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15.4%
8/52 • Number of events 14 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Skin and subcutaneous tissue disorders
Dermatology/skin - Grade 3
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1.9%
1/52 • Number of events 1 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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General disorders
Fatigue - Grade 3
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1.9%
1/52 • Number of events 1 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Blood and lymphatic system disorders
Hemoglobin - Grade 3
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3.8%
2/52 • Number of events 2 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Metabolism and nutrition disorders
Hyperglycemia - Grade 3
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13.5%
7/52 • Number of events 21 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Blood and lymphatic system disorders
Leukocytes - Grade 3
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5.8%
3/52 • Number of events 3 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Blood and lymphatic system disorders
Lymphocytes - Grade 3
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3.8%
2/52 • Number of events 4 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Blood and lymphatic system disorders
Neutrophils - Grade 3
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7.7%
4/52 • Number of events 4 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Other adverse events
| Measure |
Pre-Surgery Chemotherapy
n=52 participants at risk
Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
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|---|---|
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Blood and lymphatic system disorders
Thrombocytopenia - Grade 2
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1.9%
1/52 • Number of events 1 • 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006
All Grade 3 and 4 Adverse Events are listed under Serious Adverse Events.
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Additional Information
Gerold Bepler, M.D., Ph.D. via Moffitt Cancer Center
Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place