Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer
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Purpose
This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy
| Condition | Intervention |
|---|---|
|
Extrahepatic Bile Duct Cancer Nausea Vomiting Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer |
Drug: aprepitant Drug: gemcitabine hydrochloride Drug: capecitabine Drug: fluorouracil Procedure: radiation therapy Other: questionnaire administration Procedure: quality-of-life assessment Procedure: nausea and vomiting therapy Procedure: management of therapy complications |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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) |
- 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 [ Time Frame: Over 10 weeks ] [ Designated as safety issue: Yes ]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.
- Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
- Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | August 2006 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Drug: aprepitant
Given PO
Other Names:
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: capecitabine
Given PO
Other Names:
Drug: fluorouracil
Given IV
Other Names:
Procedure: radiation therapy
Undergo radiation therapy
Other Names:
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: nausea and vomiting therapy
Receive aprepitant
Other Names:
Procedure: management of therapy complications
Receive aprepitant
Other Name: complications of therapy, management of
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Arthur Blackstock | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01534637 History of Changes |
| Obsolete Identifiers: | NCT00398164 |
| Other Study ID Numbers: | CCCWFU 02205, NCI-2009-01258 |
| Study First Received: | February 14, 2012 |
| Results First Received: | August 29, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Nausea Pancreatic Neoplasms Vomiting Bile Duct Neoplasms Signs and Symptoms, Digestive Signs and Symptoms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Biliary Tract Neoplasms Bile Duct Diseases |
Biliary Tract Diseases Antiemetics Aprepitant Fluorouracil Gemcitabine Capecitabine Serotonin 5-HT3 Receptor Antagonists Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antimetabolites |
ClinicalTrials.gov processed this record on May 19, 2013