MDACC Study Summary 2006-0921 (Archived)

Study Summary
No. 2006-0921:.......Advanced Cancers; Anus; Biliary Tract; Bladder; Blood And Marrow Transplantation; Bone; Brain; Breast; Cancer Control; Cancer Prevention; Cervix; CNS; Colon; Colorectal; Endocrine; Endometrial; Esophageal; Eye; Fallopian Tube; Gallbladder; Gastric; Gastrointestinal; Genitourinary; GIST; Gynecology; Head And Neck; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma; Myeloma; Neural; Oropharynx; Ovary; Pancreas; Peritoneum; Prostate; Rectum; Sarcoma; Skin; Small Bowel; Solid Tumors; Spinal; Testis; Thyroid; Uterus; Vagina; Vulva......Elie Mouhayar......Cardiology

Study Summary Title



Study Summary Number:	2006-0921

Study Title:	Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers

Physician

New Patient Referral



Name:	Elie Mouhayar	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Cardiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-4197 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Anus Biliary Tract Bladder Blood And Marrow Transplantation Bone Brain Breast Cancer Control Cancer Prevention Cervix CNS Colon Colorectal Endocrine Endometrial Esophageal Eye Fallopian Tube Gallbladder Gastric Gastrointestinal Genitourinary GIST Gynecology Head And Neck Kidney Leukemia Liver Lung Lymphoma Melanoma Myeloma Neural Oropharynx Ovary Pancreas Peritoneum Prostate Rectum Sarcoma Skin Small Bowel Solid Tumors Spinal Testis Thyroid Uterus Vagina Vulva	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	8, Participants will be evaluated at baseline, 2 weeks, and approximately 4-6 weeks thereafter until month 6 after initiation of sunitinib or sorafenib chemotherapy.

Treatment Agents:	None	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to try to detect heart damage during chemotherapy, before the heart muscle weakens, by using blood tests called troponin 1 and B-type natriuretic peptide (BNP).

Study Objectives / Outcomes

Primary
1. To determine if specific biomarkers (Troponin I and B-type natriuretic peptide [BNP]) detect cardiotoxicity earlier than standard clinical means in patients receiving Sunitinib Malate (SU11248) or Sorafenib chemotherapy.

Secondary
2. To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/12/2007

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) Patient age 18-85 years

2) Starting a new course of chemotherapy at MD Anderson Cancer Center that includes sunitinib or sorafenib

3) Has a life expectancy of greater than 6 months

Exclusion Criteria:

1) Unstable angina within the last 3 months

2) Myocardial infarction within the last 3 months

3) LVEF less than 40%

4) Decompensated HF in the last 3 months

Links

Registration Number: NCT00532064
Study Information on Clinical Trials Registry (clinicaltrials.gov)