MDACC Study Summary DM02-592

Study Summary
No. DM02-592:.......Colorectal......Imad Shureiqi......Clinical Cancer Prevention

Study Summary Title



Study Summary Number:	DM02-592

Study Title:	Molecular targeting of 15-LOX-1 for apoptosis induction in human colorectal tumors

Physician

New Patient Referral



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

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

Phone:	713-745-4929 Contact us about clinical trials

General Information



Disease Group:	Colorectal	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	one return visit at 6 months of Celecoxib treatment

Treatment Agents:	Celecoxib	Home Care:	none

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	none


Description/ Intervention:	The goal of this clinical research study is to learn how (Celebrex) celecoxib affects polyp cells of the colon and rectum.

Study Objectives / Outcomes

To determine whether celecoxib downregulates GATA-6 expression to upregulate 15-LOX-1 expression and induce apoptosis in human rectal tumors, we will measure GATA-6 and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal polyp epithelial tissues before and after 6 months of celecoxib treatment of patients with familial adenomatous polyposis (FAP).

Study Status Information



Study Activation / Registration Date:	08/20/2003

IRB Review and Approval Date:	11/06/2002

Study Type:	Therapeutic

Recruitment Status:	Closed

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) Diagnosis of familial adenomatous polyposis (patients should have colorectal remnant that can be biopsied. Patients who had total colorectal surgical resection ae not eligible).

2) Adequate bone marrow function (ANC > 1500 ml, platelet count > 100,000/ml). Serum creatinine, total bilirubin, and ALT < 1.5 upper limit normal.

3) Over 16 years of age.

4) Patient is able to give an informed consent.

5) Women of childbearing potential (women are considered to be of childbearing potential unless they are at 2 or more years post-menopausal/or surgically sterile), must: a. Not be pregnant or lactating b. use adequate contraceptive measures (e.g. abstinence, IUD, birth control pills, Depo-Provera� or diaphragm or condom with spermicidal gel) starting with last menses and throughout the study duration. c. Have a negative serum pregnancy test within 14 days of starting celecoxib.

Exclusion Criteria:

1) Inflammatory bowel disease.

2) Intake of anti-inflammatory medications (e.g. non-steroidal, aspirin, and sulfasalazine) that can not be discontinued starting 3 days prior to the enrollment.

3) Chemotherapy or radiation therapy in less than three month from the time of the enrollment.

4) Individual who are taking Coumadin that can not be discontinued starting 7 days prior to the enrollment.

5) Individuals who have received an investigational chemopreventive agent during the month prior to the biopsies.

6) History of bleeding diathesis.

7) History of sulfonamides (sulfa) allergies.

8) History of cardiovascular diseases that might include the following: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.

9) Uncontrolled hypertension (>135/>85 mm Hg on three repeated measurements during the 6 weeks prior to enrollment on the study).

10) Diagnosis of Diabetes.

11) Smoking history during the 6 months prior to enrollment on the study.

12) Uncontrolled hypercholesteremia (low-density lipoprotein cholesterol (LDL-C) > 130). Hypercholesteremia needs to be controlled following the updated the National Cholesterol Education Program Adult Treatment Panel III Guidelines for at least 3 months prior to enrollment on the study. Hypercholesteremia treatment needs to be continued during the enrollment on the protocol.

13) Family history of premature coronary disease (i.e. onset <55 years of age).

14) Metabolic syndrome diagnosis in patients who are 30 years or older. (The diagnosis of metabolic syndrome is made when three or more of these risk factors are present): a. Waist circumference: Men >102 cm (>40 in); Women >88 cm (>35 in). b. Triglycerides =150 mg/dl (=1.69 mmol/L) c. High-density lipoprotein cholesterol (HDL-C): [Men <40 mg/dl (<1.03 mmol/L), Women <50 mg/dl (<1.29 mmol/L)] d. Blood pressure =130/=85 mm Hg e. Fasting glucose =110 mg/dl (=6.1 mmol/L).

15) History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies or prior heparin-induced thrombocytopenia.

Links

Registration Number: NCT00503035
Study Information on Clinical Trials Registry (clinicaltrials.gov)