celecoxib for Colorectal Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Colorectal Cancercelecoxib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying oxaliplatin, leucovorin calcium, and fluorouracil given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.

Eligible Conditions
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: At 3 years of follow-up

Year 3
Disease-free Survival
Year 3
Overall Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Experimental: Phase I/II: Celecoxib 400mg BID + RT
36%Fatigue (lethargy, malaise, asthenia)
27%Radiation dermatitis
18%Nausea
9%Hemoglobin (Hgb)
9%Confusion
9%Dysphagia-esophageal related to radiation
9%Weight loss
9%Infection without neutropenia
9%Edema
9%Vomiting
9%Late RT Toxicity: Lung
9%Anorexia
9%Headache
9%Cough
9%Pleuritic pain
This histogram enumerates side effects from a completed undefined Phase 1 & 2 trial (NCT00046839) in the Experimental: Phase I/II: Celecoxib 400mg BID + RT ARM group. Side effects include: Fatigue (lethargy, malaise, asthenia) with 36%, Radiation dermatitis with 27%, Nausea with 18%, Hemoglobin (Hgb) with 9%, Confusion with 9%.

Trial Design

4 Treatment Groups

Arm C - FOLFOX and placebo (6 treatments)
1 of 4
Arm A - FOLFOX and placebo (12 treatments)
1 of 4
Arm D - FOLFOX and celecoxib (6 treatments)
1 of 4
Arm B - FOLFOX and celecoxib (12 treatments)
1 of 4

Active Control

Experimental Treatment

2527 Total Participants · 4 Treatment Groups

Primary Treatment: celecoxib · Has Placebo Group · Phase 3

Arm D - FOLFOX and celecoxib (6 treatments)Experimental Group · 4 Interventions: 5-fluorouracil, oxaliplatin, leucovorin, celecoxib · Intervention Types: Drug, Drug, Drug, Drug
Arm B - FOLFOX and celecoxib (12 treatments)Experimental Group · 4 Interventions: 5-fluorouracil, oxaliplatin, leucovorin, celecoxib · Intervention Types: Drug, Drug, Drug, Drug
Arm C - FOLFOX and placebo (6 treatments)ActiveComparator Group · 4 Interventions: 5-fluorouracil, placebo, oxaliplatin, leucovorin · Intervention Types: Drug, Other, Drug, Drug
Arm A - FOLFOX and placebo (12 treatments)ActiveComparator Group · 4 Interventions: 5-fluorouracil, placebo, oxaliplatin, leucovorin · Intervention Types: Drug, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Celecoxib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 years of follow-up

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,068 Previous Clinical Trials
41,126,775 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
502 Previous Clinical Trials
213,045 Total Patients Enrolled
Jeffrey Meyerhardt, MD, MPHStudy ChairDana-Farber Cancer Institute
3 Previous Clinical Trials
335 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with node positive disease (N1 or N2) as designated in AJCC version 7.
Patients with synchronous colon and rectal primary tumors are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor
You have no evidence of residual involved lymph node disease or metastatic disease at the time of registration.

Who else is applying?

What state do they live in?
Nova Scotia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
PEI Cancer Treatment Centre-Queen Elizabeth Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References