Trial Outcomes & Findings for Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer (NCT NCT01534637)

Last Updated: 2018-08-15

Results Overview

Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Over 10 weeks

Results posted on

2018-08-15

Participant Flow

The study began recruiting patients 08/31/2006 and closed to enrollment 12/03/2009. Patients were recruited from the Comprehensive Cancer Center of Wake Forest Baptist Health.

Participant milestones

Participant milestones
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	22
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Physician Decision	3
Overall Study Lack of Efficacy	3
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Liver Mets before treatment	1

Baseline Characteristics

Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) n=20 Participants CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	62.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Over 10 weeks

Outcome measures

Outcome measures
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) n=20 Participants CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation	3 participants

SECONDARY outcome

Timeframe: Week 1

Outcome measures

Outcome measures
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) n=19 Participants CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs	6 participants

SECONDARY outcome

Timeframe: Week 5

Outcome measures

Outcome measures
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) n=15 Participants CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs	5 participants

Adverse Events

Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) n=21 participants at risk CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Anorexia	4.8% 1/21 • Number of events 1
Blood and lymphatic system disorders Low Leukocytes (total WBC)	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	9.5% 2/21 • Number of events 2
Vascular disorders Thrombosis/thrombus/embolism	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	4.8% 1/21 • Number of events 1
Nervous system disorders Pain: Abdomen	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders Lymphopenia	9.5% 2/21 • Number of events 2

Other adverse events

Other adverse events
Measure	Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) n=21 participants at risk CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Leukocytes (total WBC)	19.0% 4/21 • Number of events 4
Blood and lymphatic system disorders Platelets	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders Hemoglobin	23.8% 5/21 • Number of events 5
Blood and lymphatic system disorders Nausea	9.5% 2/21 • Number of events 2
Gastrointestinal disorders nausea	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders Neutrophils/granulocytes	19.0% 4/21 • Number of events 4
Metabolism and nutrition disorders Albumin, serum-low	9.5% 2/21 • Number of events 2
Metabolism and nutrition disorders Dehydration	100.0% 2/2 • Number of events 2

Additional Information

James Lovato, MS

Comprehensive Cancer Center of Wake Forest University

Phone: 336-713-4172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place