Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00398164

Purpose

RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer.

Condition	Intervention	Phase
Extrahepatic Bile Duct Cancer Nausea and Vomiting Pancreatic Cancer	Drug: aprepitant Drug: capecitabine Drug: fluorouracil Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Nausea and Vomiting Pancreatic Cancer Radiation Therapy

Drug Information available for: Fluorouracil Gemcitabine Gemcitabine hydrochloride Capecitabine Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label
Official Title:	Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV) in Patients Receiving Gemcitabine and 5-FU-Based Chemoradiation and Concurrent Upper Abdominal Radiation for Pancreatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Development of grade 3 and 4 nausea and vomiting [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall patient quality of life at baseline and weeks 1 and 5 of chemoradiotherapy [ Designated as safety issue: No ]

Estimated Enrollment:	57
Study Start Date:	August 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine if prophylaxis with aprepitant in patients with pancreatic cancer currently receiving standard chemoradiotherapy results in less nausea and vomiting when compared to historical controls.

Secondary

Determine the efficacy, in terms of the impact of emesis on daily living, of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Chemoradiotherapy: Patients undergo radiotherapy once daily 5 days a week for 5½ weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously 5 days a week or oral capecitabine twice daily 5 days a week during radiotherapy (for a total of 5½ weeks). Treatment continues in the absence of disease progression or unacceptable toxicity.
Prophylactic therapy: Patients receive oral aprepitant on days 1-3 of chemoradiotherapy (1 hour prior to beginning chemoradiotherapy). Treatment repeats every week for 5½ 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 up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients complete daily diaries to document details about their emetic episodes and the severity of nausea during chemoradiotherapy. Patients also complete the MASCC Antiemesis Tool questionnaire at baseline, at the end of week 1, and after completion of chemoradiotherapy.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the pancreas meeting any of the following criteria:
- Resectable or unresectable disease
  - Resected patients (i.e., Whipple of biliary ductal cancers) are eligible at the discretion of the principle investigator
- Potentially resectable or resectable (neoadjuvant) disease (stage II-III disease)
- Stage IV disease with symptomatic back pain requiring palliation allowed at the discretion of the principal investigator
Measurable, evaluable, or nonmeasurable disease
No neuroendocrine tumor of the pancreas
No documented brain metastasis
- Brain imaging in symptomatic patients is required to rule out metastases, but not required in asymptomatic patients
No clinically significant effusions (pleural or peritoneal) that cannot be drained

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
Albumin ≥ 3.0 g/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No active infection
No serious concurrent systemic disorders that would preclude study compliance
No significant cardiovascular disease in the form of abnormal ECG coupled with clinical features of recent or recurrent cardiac disease, including any of the following:
- Myocardial infarction
- Angina
- Hypertension

PRIOR CONCURRENT THERAPY:

No prior chemotherapy for pancreatic cancer
More than 4 weeks since prior investigational agents
No concurrent oprelvekin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398164

Locations

United States, North Carolina
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Arthur William Blackstock, MD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wake Forest University Comprehensive Cancer Center ( Arthur William Blackstock )
Study ID Numbers:	CDR0000511906, CCCWFU-02205, CCCWFU-EMEND, MERCK-CCCWFU-02205
Study First Received:	November 9, 2006
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00398164 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

stage I pancreatic cancer
adenocarcinoma of the pancreas
extrahepatic bile duct cancer

Study placed in the following topic categories:

Antimetabolites
Vomiting
Immunologic Factors
Signs and Symptoms, Digestive
Pancreatic Neoplasms
Antiemetics
Bile Duct Cancer, Extrahepatic
Pancrelipase
Signs and Symptoms
Biliary Tract Diseases
Nausea
Gemcitabine
Endocrine Gland Neoplasms
Aprepitant
Capecitabine

Digestive System Neoplasms
Biliary Tract Neoplasms
Endocrine System Diseases
Antiviral Agents
Immunosuppressive Agents
Serotonin
Digestive System Diseases
Radiation-Sensitizing Agents
Bile Duct Diseases
Fluorouracil
Pancreatic Diseases
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Bile Duct Neoplasms
Endocrinopathy

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Vomiting
Antimetabolites, Antineoplastic
Immunologic Factors
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Antiemetics
Signs and Symptoms
Neoplasms by Site
Therapeutic Uses
Biliary Tract Diseases

Nausea
Gemcitabine
Endocrine Gland Neoplasms
Aprepitant
Capecitabine
Digestive System Neoplasms
Biliary Tract Neoplasms
Gastrointestinal Agents
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on May 07, 2009