A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus
Celecoxib or Placebo for Patients with Resected Stage III Colon
This is a phase II , multi-center clinical trial that randomizes patients into 1 of 4 different treatment arms. Patients are first randomized to 6 or 12 cycles of mFOLFOX6 chemotherapy (the standard chemotherapy) and then to either Celecoxib or placebo to be continued after the chemotherapy is completed. The goals of this trial are to determine whether 1) celecoxib can prevent cancer recurrence and 2) whether six cycles of FOLFOX is as good as 12 cycles of FOFLOX in preventing cancer recurrence. Celecoxib is FDA approved for the treatment of arthritis, and has also been shown to help decrease the chances of cancer recurrence. FOLFOX is administered every 2 weeks at UCSF. Patients will take the Celexoxib or placebo every day during chemotherapy and continue to take it daily for 3 years total. Patients will be monitored every 6 months after chemotherapy with office visits and tumor assessment scans to monitor
Site PI: Alan Venook, MD

Contact: Sharvina Ziyeh, 415-353-7683

Eligibility Criteria:
1. Patient can begin study treatment between 21 and 56 days after definitive surgical resection of primary tumor and within 14 days of randomization. 2. Patient has histologically documented adenocarcinoma of the colon. 3. The gross inferior (caudad) margin of the patient’s primary tumor lies above the 4. peritoneal reflection (i.e., patients w/ rectal cancer are not eligible). Surgeon 5. that tumor was above peritoneal reflection is only required when it 6. is important to establish rectal vs. colon primary. 7. Patient’s tumors have been completely resected. (If tumor is adherent to adjacent structures, en bloc R ۪◌ resection is documented in the operative report. Near or positive radial margin allowed as long as en bloc resection was performed. Positive proximal 8. Patient has node positive disease (N1 or N2) as designated in AJCC v7. Either at least 9. one pathological y confirmed positive lymph node or N1C (defined as tumor 10. deposit in the subserosa, mesentery, or nonperitonealized pericolic or perirectal 11. tissues without regional lymph node metastases). 14. Patient has following initial lab values: 1. Patient has evidence of residual involved lymph node disease or metastatic disease at 2. Patient has synchronous colon and rectal primary tumors. (However, synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of more 3. Patient plans to continue taking NSAIDs more than 2 times per week. 4. Patient plans to continue taking aspirin at >325 mg at least 3 times per week. (Low-dose aspirin not exceeding 100 mg/day is permitted). 5. Patient has previous or concurrent malignancy. (Treated basal or squamous cell skin cancer, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, and any cancer where patient has been disease-free for at least 5 years is 6. Patient has neurosensory or neuromotor toxicity grade 2 or higher at time of 7. Patient is allergic to platinum compounds. 8. Patient has had allergic reaction or hypersensitivity to sulfonamides, celecoxib, or 9. Patient has history of upper GI ulceration, upper GI bleeding, or upper GI perforation 10. Patient has symptomatic pulmonary fibrosis. 11. Patient has interstitial pneumonitis grade 2 or higher. 12. Patient has any of the following cardiac risk factors: • Uncontrol able high blood pressure (systolic blood pressure above 150) • History of documented myocardial infarction or cerebrovascular accident • NY Heart Association class II or IV heart failure 13. Patient is pregnant, nursing, or wil not agree to use contraception during study and for 8 weeks following completion of chemotherapy.


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