Purpose

PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.

Category

IRB Number
20150182HU
NCT Number
NCT01150045
Open to Enrollment
Yes
Sponsor
Alliance for Clinical Trials in Oncology -



Study Contact

Principal Investigator
Sukeshi Arora

Sukeshi Arora
(210) 450-1015
aroras@uthscsa.edu

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      Double (Participant, Investigator)
      Condition
    1. Colorectal Cancer

      2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm B - FOLFOX and celecoxib (12 treatments)

      		Patients receive FOLFOX every 2 weeks plus celecoxib every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.
    2. Drug: celecoxib

      Patients receive celecoxib 400 mg administered by mouth, once daily.

    3. Drug: leucovorin

      Patients receive 400 mg/m^2 intravenous over two hours.

    4. Drug: 5-fluorouracil

      Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.

    5. Drug: oxaliplatin

      Patients receive 85 mg/m^2 intravenous over two hours.

      6. Experimental

      Arm D - FOLFOX and celecoxib (6 treatments)

      		Patients receive FOLFOX every 2 weeks plus celecoxib every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.
    6. Drug: celecoxib

      Patients receive celecoxib 400 mg administered by mouth, once daily.

    7. Drug: leucovorin

      Patients receive 400 mg/m^2 intravenous over two hours.

    8. Drug: 5-fluorouracil

      Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.

    9. Drug: oxaliplatin

      Patients receive 85 mg/m^2 intravenous over two hours.

      10. Active Comparator

      Arm A - FOLFOX and placebo (12 treatments)

      		Patients receive FOLFOX every 2 weeks plus placebo every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.
    10. Other: placebo

      Patients receive placebo administered by mouth, once daily.

    11. Drug: leucovorin

      Patients receive 400 mg/m^2 intravenous over two hours.

    12. Drug: 5-fluorouracil

      Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.

    13. Drug: oxaliplatin

      Patients receive 85 mg/m^2 intravenous over two hours.

      14. Active Comparator

      Arm C - FOLFOX and placebo (6 treatments)

      		Patients receive FOLFOX every 2 weeks plus placebo every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.
    14. Other: placebo

      Patients receive placebo administered by mouth, once daily.

    15. Drug: leucovorin

      Patients receive 400 mg/m^2 intravenous over two hours.

    16. Drug: 5-fluorouracil

      Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.

    17. Drug: oxaliplatin

      Patients receive 85 mg/m^2 intravenous over two hours.

      18.