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Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer


OBJECTIVES:

Primary

- Determine the objective response rate in patients with locally recurrent or metastatic
colorectal cancer treated with celecoxib, capecitabine, and irinotecan.

Secondary

- Determine the time to progression in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the overall survival of patients treated with this regimen.

- Determine the time to treatment failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily on days -7 to 21 during course 1 and on days
1-21 in all subsequent courses. Patients also receive oral capecitabine twice daily on days
1-14 and irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity. Patients achieving a complete or
partial response after 4 courses may temporarily discontinue treatment for no more than 4
weeks.

After completion of study treatment, patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 21-44 patients will be accrued for this study within 7-18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon or rectum

- Locally recurrent or metastatic disease

- Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan
OR ≥ 10 mm by spiral CT scan

- Bone metastases, ascites, and pleural effusion are not considered measurable
disease

- Measurable lesions must be located outside a previously irradiated field

PATIENT CHARACTERISTICS:

Performance status

- SWOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- No Gilbert's disease

Renal

- Creatinine clearance > 50 mL/min

Cardiovascular

- No clinically significant cardiac disease that is not well controlled by medication,
including any of the following conditions:

- Congestive heart failure

- Symptomatic coronary artery disease

- Cardiac arrhythmias

- No myocardial infarction within the past year

Gastrointestinal

- Must have a physically intact upper gastrointestinal tract

- Able to swallow tablets

- No history of peptic ulcer disease or gastroesophageal reflux

- No malabsorption syndrome

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or
other nonsteroidal anti-inflammatory drugs

- No other malignancy except curatively treated cancer with no evidence of active
disease

- No unresolved bacterial infection requiring antibiotics

- No other serious infection

- No known allergy to study drugs or sulfa drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for colorectal cancer

- Patients relapsing > 6 months after completion of prior adjuvant chemotherapy
allowed

- No other concurrent anticancer chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy

- No concurrent anticancer radiotherapy

Surgery

- Recovered from prior surgery

- No concurrent anticancer surgery

Other

- Prior celecoxib for nonmalignant disorders allowed

- No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory
drugs, including any of the following:

- Rofecoxib

- Ibuprofen

- Naproxen

- Etodolac

- Oxaprozin

- Diflunisal

- Nabumetone

- Tolmetin

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate by RECIST criteria at every other course

Safety Issue:

No

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445439

NCT ID:

NCT00258232

Start Date:

January 2002

Completion Date:

August 2007

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • recurrent colon cancer
  • recurrent rectal cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240