Trial Outcomes & Findings for Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer (NCT NCT00310050)
NCT ID: NCT00310050
Last Updated: 2018-11-30
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
42 days
Results posted on
2018-11-30
Participant Flow
Participant milestones
| Measure |
Pemetrexed in Combination With Concomitant Radiotherapy
Patients will receive Pemetrexed plus Radiotherapy.
pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
|
|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed in Combination With Concomitant Radiotherapy
n=4 Participants
Patients will receive Pemetrexed plus Radiotherapy.
pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
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|---|---|
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Age, Continuous
|
61.5 years
STANDARD_DEVIATION 2.645 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: data were not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 42 daysPopulation: data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 daysPopulation: Data available for 2 participants.
Toxicity will be determined using the revised NCI Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Number of events with grade 1-5 will be reported.
Outcome measures
| Measure |
Pemetrexed in Combination With Concomitant Radiotherapy
n=2 Participants
Patients will receive Pemetrexed plus Radiotherapy.
pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
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|---|---|
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Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy
Grade 1
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22 events
|
|
Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy
Grade 2
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7 events
|
|
Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy
Grade 3
|
3 events
|
|
Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy
Grade 4
|
0 events
|
|
Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy
Grade 5
|
0 events
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data not collected on all participants.
Outcome measures
| Measure |
Pemetrexed in Combination With Concomitant Radiotherapy
n=3 Participants
Patients will receive Pemetrexed plus Radiotherapy.
pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
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|---|---|
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Patterns of Response
Partial Response
|
1 Participants
|
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Patterns of Response
Stable disease
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2 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Pemetrexed in Combination With Concomitant Radiotherapy
n=3 Participants
Patients will receive Pemetrexed plus Radiotherapy.
pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
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|---|---|
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Number of Participants That Survived
|
2 Participants
|
Adverse Events
Pemetrexed in Combination With Concomitant Radiotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pemetrexed in Combination With Concomitant Radiotherapy
n=4 participants at risk
Patients will receive Pemetrexed plus Radiotherapy.
pemetrexed disodium: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
Radiotherapy: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
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|---|---|
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Gastrointestinal disorders
ALT, SGPT
|
25.0%
1/4 • up to 1 year
|
|
Gastrointestinal disorders
Alkaline phosphatase
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25.0%
1/4 • up to 1 year
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
1/4 • up to 1 year
|
|
Blood and lymphatic system disorders
Calcium, serum-high
|
25.0%
1/4 • up to 1 year
|
|
Blood and lymphatic system disorders
Calcium, serum-low
|
25.0%
1/4 • up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • up to 1 year
|
|
Renal and urinary disorders
Dehydration
|
25.0%
1/4 • up to 1 year
|
|
General disorders
Dizziness
|
25.0%
1/4 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Edema
|
25.0%
1/4 • up to 1 year
|
|
General disorders
Fatigue
|
25.0%
1/4 • up to 1 year
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.0%
1/4 • up to 1 year
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
50.0%
2/4 • up to 1 year
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
50.0%
2/4 • up to 1 year
|
|
Metabolism and nutrition disorders
Glucose, serum-low
|
25.0%
1/4 • up to 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin (gender based)
|
50.0%
2/4 • up to 1 year
|
|
Infections and infestations
Infection - Other
|
25.0%
1/4 • up to 1 year
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
25.0%
1/4 • up to 1 year
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) (4.8-10.8)
|
50.0%
2/4 • up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • up to 1 year
|
|
Nervous system disorders
Neurology - Other
|
25.0%
1/4 • up to 1 year
|
|
Nervous system disorders
Neuropathy
|
25.0%
1/4 • up to 1 year
|
|
Immune system disorders
Neutrophils/granulocytes (ANC/AGC) 1.6-7.3
|
50.0%
2/4 • up to 1 year
|
|
Eye disorders
Ocular/Visual - Other
|
25.0%
1/4 • up to 1 year
|
|
General disorders
Pain - Other
|
25.0%
1/4 • up to 1 year
|
|
Gastrointestinal disorders
Pain
|
25.0%
1/4 • up to 1 year
|
|
Blood and lymphatic system disorders
Platelets
|
25.0%
1/4 • up to 1 year
|
|
Blood and lymphatic system disorders
Potassium, serum-high
|
25.0%
1/4 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • up to 1 year
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
25.0%
1/4 • up to 1 year
|
|
Renal and urinary disorders
Sodium, serum-high
|
25.0%
1/4 • up to 1 year
|
|
Eye disorders
Watery eye
|
25.0%
1/4 • up to 1 year
|
Additional Information
Dr. William Blackstock
Wake Forest University Health Sciences
Phone: 3367136501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place