Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Conditions

• Colon Adenocarcinoma
• Stage IIA Colon Cancer AJCC v7
• Stage IIB Colon Cancer AJCC v7
• Stage IIC Colon Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Fluorouracil — DRUG
  Given IV
• Leucovorin — DRUG
  Given IV
• Oxaliplatin — DRUG
  Given IV

Study Details

This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.

Key Dates

First listed

Sep 22, 2005

Start date

Sep 6, 2005

Status verified

Apr 2026

Primary completion

Feb 22, 2024

Completion

Apr 11, 2027

Study Design

Enrollment

2,431 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (5-FU, leucovorin, oxaliplatin)
  Patients receive oxaliplatin IV over 2 hours and leucovorin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (5-FU, leucovorin, oxaliplatin, bevacizumab)
  Patients receive oxaliplatin, leucovorin, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
• No Intervention: Arm C (observation)
  Patients undergo observation.

Primary Outcome Measure

Disease-free Survival Rate at 5 Years [ Time Frame: Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization ]

Locations (911)

Find similar trials in Anniston, AL

Related Studies

• Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
  PHASE1 · Recruiting · University of California, Irvine · Orange, California
• Evaluating Novel Therapies in ctDNA Positive GI Cancers
  PHASE3 · Recruiting · Georgetown University · Washington D.C., District of Columbia
• Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test
  Recruiting · Mainz Biomed · Morrisville, North Carolina
• A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
  PHASE3 · Recruiting · Merck Sharp & Dohme LLC · Los Angeles, California