Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
18 Years
N/A
Both
Colorectal Cancer
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 Center | Ann Arbor, Michigan 48109-0752 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
