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(members only)
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NSABP P-5 - "Statin Polyp Prevention Trial in Patients with Resected Colon Cancer"
Treatment Plan (Supplied Drug: Rosuvastatin/placebo)
RANDOMIZATION
Group 1
Placebo: 1 tab, QD, x 5 yrs
Group 2
Rosuvastatin: 10mg tab, QD, x 5 yrs
Eligibility
Age >18.
ECOG perf status 0-1.
Ability to swallow PO meds.
Must have had resected colon adenocarcinoma, AJCC Stg I or II.
Surgical resection of colon w/curative intent w/i 1 yr pre-randomiz. Laparoscopically-assisted colectomy is allowed.
Completed any adjuv therapy pre-randomiz.
If taking cardioprotective low-dose aspirin at study entry, must not have clinically significant toxicity (investigator's opinion) that precludes continuation of aspirin. Pt must be willing to continue aspirin therapy (81mg or 325mg) throughout study therapy.
Within 180 days pre-randomiz:
Must have undergone pre-op or post-op documented colonoscopy to the cecum (or small bowel anastomosis) w/adequate bowel prep.
All observed polyps removed. (Polyps can be removed during colonoscopy or surgery performed pre-randomiz.)
Within 90 days pre-randomiz: Post-op serum creat <1.5x ULN.
Post-op testing w/i 90 days pre-randomiz: SGOT or SGPT <3.0x ULN; total bili <1.5x ULN. If both SGOT & SGPT are performed, each must be <3.0x ULN.
No tumor w/distal border <12cm from anal verge.
No total colectomy or total proctocolectomy.
No Classic Familial Adenomatous Polyposis, Attentuated Familial Adenomatous Polyposis (i.e., >20 adenomas, either synchronous or metachronous), or Hereditary Nonpolyposis Colorectal Cancer (Lynch Syndrome).
No malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of stomach or small bowel, or other disease significantly affecting GI function.
No documented upper GI bleeding or upper GI ulcerative disease.
No statin use w/i 30 days pre-randomiz.
No hyperlipidemia w/clinical indication for statin therapy or other prescribed meds (using current dyslipidemia mgmt guidelines).
Must D/C chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81mg or 325mg) pre-randomiz.
No anticipated need for chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81mg or 325mg).
No inadequately treated hypothyroidism (investigator's determination).
No prior myopathy or rhabdomyolysis.
No hypersensitivity or intolerance to statins.
No chronic drug therapy w/cyclosporine, coumarin anticoagulants, gemfibrozil, some other lipid-lowering therapies (fibrates or niacin), lopinavir/ritonavir, or drugs that lower levels or activity of steroid hormones.
No pregnant or lactating women. Pregnancy test (if applicable) w/i 14 days pre-randomiz must be negative.
No prior malignancies unless disease-free >5 yrs pre-randomiz and at low risk for recurrence (physician's opinion). Following cancers are allowed if diagnosed & treated w/i past 5 yrs: all in situ cancers & non-melanoma skin cancer.
No other non-malignant systemic disease to preclude receiving Rosuvastatin or prevent prolonged follow-up.
No use of any investigational agent w/i 30 days pre-randomiz.
PRESTUDY REQUIREMENTS:
H&P w/GI hx, ht, wt*
Calcium & Vit D supplement use*
Colorectal cancer family hx*
Perf status*
Serum creat (post-op)*
SGOT or SGPT & total bili (post-op)*
Fasting lipid panel (total, LDL, HDL, & triglycerides)*
Pregnancy test (if applicable, w/i 14 days pre-randomiz)
Colonoscopy (to cecum [or small bowel anastomosis] w/adequate bowel prep) - w/i 180 days pre-randomiz
Behavioral & Health Outcomes (BAHO) Questionnaire
Serum & blood (w/pt's consent)**
* Within 90 days pre-randomiz
** Contact KCCOP for kit. 1 yellow-top & 3 red-top tubes of blood. Process per protocol & ship same day as collected via overnight delivery (Mon-Thur only). Send on cold packs frozen at -20oC overnight b/f shipping. Use pre-printed airbill for Baylor College of Medicine Breast Center; Houston, TX.
Signed informed consent.