A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV)
18 Years
N/A
Both
Extrahepatic Bile Duct Cancer, Nausea, Vomiting, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
Trial Information
A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV)
PRIMARY OBJECTIVES:
I. Discern the gastrointestinal toxicities associated with 5-FU (fluorouracil)/Gemcitabine
(gemcitabine hydrochloride) chemotherapy when combined with upper abdominal radiation
therapy.
II. Determine if the addition of prophylactic Aprepitant/5HT-3/Dexamethasone therapy to
standard chemoradiation for patients with pancreatic cancer results in less nausea and
vomiting when compared to historical controls.
SECONDARY OBJECTIVES:
I. To determine the impact of prophylactic Aprepitant/5HT-3/Dexamethasone therapy on the
impact of emesis on daily living, as measured using the MASCC Antiemesis (MAT) tool.
OUTLINE:
CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks.
Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once
weekly and either fluorouracil IV continuously or capecitabine orally (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.
After completion of study treatment, patients are followed periodically.
Inclusion Criteria:
- Histologic or cytologic diagnosis of carcinoma arising from the pancreas
- Resected or unresectable pancreatic cancer, potentially resectable, or resectable
(neoadjuvant) disease (stage II and III); stage IV patients with symptomatic back
pain requiring palliation are also eligible at the discretion of the Principal
Investigator (PI); resected patients, i.e. - "Whipple" of biliary ductal cancers are
also eligible at the discretion of the PI
- Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Evidence of disease; this can be measurable, evaluable, or nonmeasurable
- Estimated life expectancy of at least 12 weeks
- Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 X 10^9/L
- Platelets >= 100 X 10^9/L
- Hemoglobin >= 9 g/dL
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase (AP) =< 3.0 ULN ( AP =< 5 x ULN is acceptable if liver has tumor
involvement)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 ULN (AST
and ALT =< 5 x ULN is acceptable if liver has tumor involvement)
- Albumin >= 3.0 g/dL
- Signed informed consent from patient
- Male and female patients with reproductive potential must use an approved
contraceptive method (e.g., intrauterine device, birth control pills, or barrier
device) during and for 3 months after the study
Exclusion Criteria:
- Active infection (at the discretion of the investigator)
- Neuroendocrine tumor of the pancreas
- Documented brain metastasis; brain imaging in symptomatic patients is required to
rule out metastases, but not required in asymptomatic patients
- Pregnancy
- Breast feeding
- Serious concomitant systemic disorders incompatible with the study (at the discretion
of the investigator)
- Use of any investigational agent within 4 weeks before enrollment into the study
- Significant cardiovascular disease in the form of abnormal electrocardiogram (ECG)
coupled with clinical features of recent or recurrent cardiac disease (including
myocardial infarction, angina or hypertension)
- Prior treatment with chemotherapy for pancreatic cancer
- Clinically significant effusions (pleural or peritoneal) that cannot be drained
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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
Outcome Description:
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.
Outcome Time Frame:
Over 10 weeks
Safety Issue:
Yes
Principal Investigator
Arthur Blackstock
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 02205
NCT ID:
NCT01534637
Start Date:
August 2006
Completion Date:
August 2012
Related Keywords:
- Extrahepatic Bile Duct Cancer
- Nausea
- Vomiting
- Stage II Pancreatic Cancer
- Stage III Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Nausea
- Pancreatic Neoplasms
- Vomiting
- Bile Duct Neoplasms
Name | Location |
|---|---|
| Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
