Upstate Active Clinical Trials Seeking Participants
Study title
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
IRB number
CIRB117
What is the purpose of the study?
This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called FOLFOX . At the present time, the Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, we will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis. It is also approved to help prevent colon polyps in families with a genetic risk for colon cancer. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOFLOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care for this stage of colon cancer is 12 treatments with FOLFOX. That was the number of treatments tested in previous research studies. However, it is not known if fewer treatments would be as helpful in preventing the cancer from coming back. In this trial, we will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. If you participate in this study, you may be assigned to the group receiving only 6 treatments, which would be fewer treatments than the standard of care (12 treatments).
Who is eligible?
Histologically confirmed adenocarcinoma of the colon, Stage III disease, No rectal cancer, completely resected tumor, ECOG performance status 0-2, Granulocyte count e 1,500/?L, Platelet count e 100,000/?L, Creatinine d 1.5 times upper limit of normal (ULN), Bilirubin d 1.5 times ULN, Not pregnant or nursing, Negative pregnancy test, Fertile patients must use effective contraception during and for 8 weeks after completion of chemotherapy, No prior or concurrent malignancy except treated basal cell or squamous cell cancer of the skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in 1 breast, or any other cancer for which the patient has been disease-free for e 5 years, No neurosensory or neuromotor toxicity e grade 2, No known allergy to platinum compounds, No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, or NSAIDs, No history of upper gastrointestinal ulceration, bleeding, or perforation within the past 3 years, No symptomatic pulmonary fibrosis or interstitial pneumonitis e grade 2, No cardiac risk factors including, but not limited to, any of the following:
o Uncontrolled high blood pressure (BP) (systolic BP > 150 mm Hg)
o Unstable angina
o History of documented myocardial infarction or cerebrovascular accident
o NYHA class III-IV heart failure
No concurrent NSAIDs or aspirin at > 325 mg e 3 times per week on average
o Low-dose aspirin not exceeding 100 mg/day allowed
What is involved if I participate?
- How long is the study?
Subjects will be treated with the FOLFOX chemotherapy for up to 6 treatments (12 weeks) or 12 treatments (24 weeks) (depending on their treatment arm) and the celecoxib or placebo capsule for up to 3 years. Some or all of the treatments would be stopped if subjects become too sick to receive the therapy, if their doctor believes another treatment is appropriate, or if subjects no longer wish to continue with the study. Whether or not subjects remain on study treatment, the doctor will continue to follow their progress at least every 6 months for up to 6 years after they started treatment. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Medical history and physical examination, Blood tests, a pregnancy test, liver function tests, CT, MRI scan, or ultrasound of the abdomen and chest CT or X-ray.
Who is the doctor administering the study?
Jonathan Wright, MD
Where will the study take place?
Hospital, Hematology/Oncology Clinics in Oswego, Oneida and at Hill Medical Center.
Over what time period is the study scheduled to run?
7/2010 to ongoing
Who can I contact for more information?
- Name: Wendy Barry
- Phone: 315-464-8271
- Email: barryw@upstate.edu
If you are interested in this trial, please contact the study coordinator or investigator noted above.
