MDACC Study Summary 2006-1033 (Archived)

Study Summary
No. 2006-1033:.......Lymphoma......Saroj Vadhan-Raj......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2006-1033

Study 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

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7966 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	Merck and Company

Phase of Study:	N/A	Return Visit:	Twice weekly CBC.

Treatment Agents:	Aprepipant Cyclophosphamide Doxorubicin Prednisone Rituximab Vincristine	Home Care:	Aprepitant is an oral agent and may be taken at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	PK samples collected first 24 hours for 2 cycles.Typical duration of inpatient chemotherapy 48-72 hours. Each cycle is typically 14 to 21 days apart or per discretion of the treating physician.


Description/ Intervention:	The goal of this clinical research study is 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. Researchers also want 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.

Study Objectives / Outcomes

Primary:

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

Secondary/Exploratory:
1) 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.
2) Compare treatment groups for other clinical endpoints such as degree of myelosuppression, neutropenic fever, hyperglycemia, and neuropathy.

Study Status Information



Study Activation / Registration Date:	03/14/2008

IRB Review and Approval Date:	03/14/2008

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Newly diagnosed or relapsed lymphoid malignancy.

2) 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

3) Age >/= to 18 years

4) Adequate organ function defined as serum total bilirubin < 1.2 mg/dl, serum aspartate aminotransferase or alanine aminotransferase < 60 IU/L, creatinine < 1.5 mg/dL.

Exclusion Criteria:

1) Evidence of neoplastic central nervous system disease

2) Patients who are unable to take oral medication (e.g. due to tumor obstruction)

Links

Registration Number: NCT00651755
Study Information on Clinical Trials Registry (clinicaltrials.gov)