MDACC Study Summary NSABP-P5

Study Summary
No. NSABP-P5:.......Colorectum......Therese B. Bevers......Clinical Cancer Prevention

Study Summary Title



Study Summary Number:	NSABP-P5

Study Title:	Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

Physician

New Patient Referral



Name:	Therese B. Bevers	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:	713-745-8040 Contact us about clinical trials

General Information



Disease Group:	Colorectum	Supported By:	NCI The National Surgical Adjuvant Breast and Bowel Project

Phase of Study:	Phase III	Return Visit:

Treatment Agents:	Rosuvastatin	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if Crestor (rosuvastatin) is able to help prevent colon polyps from forming and/or colon cancer from returning in patients that have had colon cancer removed by surgery. Another reason for doing this study is to learn about the side effects of rosuvastatin when give to preven the development of polyps and new colorectal cancer.

Study Objectives / Outcomes

This Phase III randomized, placebo-controlled, double-blind study will evaluate the effectiveness
of the HMG-CoA reductase inhibitor rosuvastatin in preventing the occurrence of adenomatous
polyps of the colon or rectum, metachronous colorectal carcinoma, and colon cancer recurrence
(APMC+R) among colon cancer patients treated for cure. Secondary aims of the study will be to
evaluate the impact of rosuvastatin compared to placebo on the time to APMC+R; the size,
number, and features of colorectal adenomas; the rate of colon cancer recurrence; the rate of
second non-colorectal primary invasive cancers; and the impact on disease-free survival and
survival. The toxicity of rosuvastatin compared to placebo will also be determined. Quality of
life and symptoms will also be compared. The P-5 secondary aims also include plans for analysis
of APMC+R comparing patients regularly taking aspirin to those not taking aspirin, determining
whether there is synergy between aspirin and statin, and by the analysis of APMC+R in the
sub-groups of patients with familial colorectal cancer and patients with microsatellite unstable
tumors. The P-5 study will provide the opportunity to explore potential tumor and blood markers
for benefit from rosuvastatin.

Study Status Information



Study Activation / Registration Date:	09/16/2010

IRB Review and Approval Date:	09/16/2010

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	1,740

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) The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines.

2) Patients must be 18 years of age or older.

3) Patients must have an ECOG performance status of 0 or 1

4) Patients must have the ability to swallow oral medication.

5) Patients must have resected adenocarcinoma of the colon staged as AJCC Stage 0, I, II, or III.

6) Patients must have had surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to randomization. (Laparoscopically-assisted colectomy is permitted.)

7) Patients must have completed any adjuvant therapy prior to randomization.

8) Patients who are taking cardioprotective low-dose aspirin at study entry must not have clinically significant toxicity, as determined by the investigator, that precludes continuation of aspirin, and the patient must be willing to continue aspirin therapy (81 mg or 325 mg) throughout study therapy.

9) Colonoscopy requirements within 180 days prior to randomization: • The patient must have either undergone a preoperative or postoperative documented colonoscopy to the cecum (or small bowel anastomosis) with adequate bowel preparation. • All observed polyps must have been removed.(Polyps can be removed during colonoscopy or surgery performed prior to randomization.)

10) Postoperative serum creatinine performed within 90 days prior to randomization must be less than or equal to 1.5 x ULN for the lab.

11) The following criteria for evidence of adequate hepatic function based on postoperative testing performed within 90 days prior to randomization must be met: • AST or ALT less than or equal to 3.0 x ULN for the lab, and • Total bilirubin less than or equal to 1.5 x ULN for the lab

Exclusion Criteria:

1) Tumor with the distal border located < 12 cm from the anal verge.

2) Total colectomy or total proctocolectomy.

3) Classic Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis (i.e., 20 or more adenomas, either synchronous or metachronous), or Hereditary Nonpolyposis Colorectal Cancer (Lynch Syndrome).

4) Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function.

5) History of documented upper GI bleeding or upper GI ulcerative disease.

6) Statin use within 30 days prior to randomization.

7) Hyperlipidemia with clinical indication for statin therapy or other prescribed medication. Determination of acceptable fasting lipid values, within 90 days prior to randomization, should be in accordance with current dyslipidemia management guidelines.

8) Unwillingness to discontinue chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81 mg or 325 mg) prior to randomization.

9) Anticipated need for chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81 mg or 325 mg).

10) Inadequately treated hypothyroidism, as determined by the investigator.

11) History of myopathy or rhabdomyolysis.

12) Hypersensitivity or intolerance to statins.

13) Chronic drug therapy with cyclosporine, coumarin anticoagulants, gemfibrozil, some other lipid-lowering therapies (fibrates or niacin), lopinavir/ritonavir, or drugs (such as ketoconazole, spironolactone, or cimetidine) that lower levels or activity of steroid hormones.

14) Pregnancy or lactation at the time of study entry. (Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of childbearing potential.)

15) Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.

16) Other non-malignant systemic disease that would preclude a patient from receiving rosuvastatin or would prevent prolonged follow-up.

17) Administration of any investigational agent within 30 days before randomization.

Links

Registration Number: NCT01011478
Study Information on Clinical Trials Registry (clinicaltrials.gov)