Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Merck and Company
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00651755

Purpose

Primary Objective:

Determine the magnitude of aprepitant's inhibition of cyclophosphamide, vincristine, and prednisone metabolism using pharmacokinetic (PK) sampling.

Secondary/Exploratory Objectives:

Assess the efficacy of aprepitant in the prevention of nausea and vomiting in patients receiving the moderately-highly emetogenic multi-day chemotherapy regimen of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)/Rituximab (R)-CHOP.
Compare treatment groups for other clinical endpoints such as degree of myelosuppression, neutropenic fever, hyperglycemia, and neuropathy.

Condition	Intervention
Lymphoma	Drug: Aprepitant Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Rituximab

MedlinePlus related topics: Cancer Lymphoma Nausea and Vomiting

Drug Information available for: Cyclophosphamide Prednisone Vincristine Doxorubicin Doxorubicin hydrochloride Myocet Aprepitant Rituximab Vincristine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn the effect of combining aprepitant with CHOP or R-CHOP in patients with NHL that is either newly diagnosed or has come back. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aprepitant + CHOP Regimen	Drug: Aprepitant 125 mg PO On Day 1, followed by 80 mg PO Daily On Days 2-3. Drug: Cyclophosphamide 750 mg/m^2 IV On Day 1 Drug: Doxorubicin 25 mg/m^2 IV Over 48 Hours On Days 1-2 Drug: Vincristine 2 mg IV On Day 1 Drug: Prednisone 100 mg PO x 5 Days
2: Experimental Aprepitant + R-CHOP Regimen	Drug: Aprepitant 125 mg PO On Day 1, followed by 80 mg PO Daily On Days 2-3. Drug: Cyclophosphamide 750 mg/m^2 IV On Day 1 Drug: Doxorubicin 25 mg/m^2 IV Over 48 Hours On Days 1-2 Drug: Vincristine 2 mg IV On Day 1 Drug: Prednisone 100 mg PO x 5 Days Drug: Rituximab 375 mg/m^2 IV On Day 1.

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Eligibility

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

Criteria

Inclusion Criteria:

Newly diagnosed or relapsed lymphoid malignancy.
Patients receiving either:(1) Bolus or 48-hr infusion CHOP (cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given as bolus infusion or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg x 5 days) OR (2) Bolus or 48-hr infusion R-CHOP (Rituximab 375mg/m^2 on Day 1+ CHOP as above). (For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician
Age >/= to 18 years
Adequate organ function defined as serum total bilirubin </= 1.2 mg/dL, serum aspartate aminotransferase or SGOT </= 60 IU/L, creatinine < 1.5 mg/dL.

Exclusion Criteria:

Evidence of neoplastic central nervous system disease
Patients who are unable to take oral medication (e.g. due to tumor obstruction)
History of Diabetes Mellitus (Diabetes as defined by established diagnosis of diabetes currently receiving medications for the diabetes management and/or a fasting blood glucose of >/= 126 mg/dL.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651755

Contacts

Contact: Saroj Vadhan-Raj, MD

713-792-7966

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Saroj Vadhan-Raj, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Merck and Company

Investigators

Principal Investigator:

Saroj Vadhan-Raj, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor )
Study ID Numbers:	2006-1033
Study First Received:	March 31, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00651755 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Non-Hodgkin's Lymphoma
Lymphoma
Nausea
Cyclophosphamide
Cytoxan
Neosar
Doxorubicin
AD
Hydroxydaunomycin hydrochloride
Vincristine
Prednisone

Rituximab
Rituxan
Aprepitant
Emend
L754030
MK869
Drug Metabolism
CHOP
R-CHOP
NHL

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
Hormones
Lymphoma, Small Cleaved-cell, Diffuse
Anti-Bacterial Agents
Nausea
Lymphoma
Alkylating Agents
Aprepitant
Immunoproliferative Disorders

Antineoplastic Agents, Hormonal
Rituximab
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Lymphatic Diseases
Tubulin Modulators
Peripheral Nervous System Agents
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Lymphoma
Alkylating Agents
Aprepitant

Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Mitosis Modulators
Gastrointestinal Agents
Vincristine
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009