Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer

NCT ID: NCT00258232

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2007-08-31

Brief Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.

Detailed Description

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

capecitabine

Intervention Type: DRUG

celecoxib

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip A. Philip, MD, PhD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, United States

Countries

United States

References

El-Rayes BF, Venkat R, Heilbrun LK: A dose attenuated schedule of irinotecan and capecitabine in combination with celecoxib in advanced colorectal cancer. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-254, 2006.

Reference Type: RESULT

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-C-2424

Identifier Type: -

Identifier Source: secondary_id

CDR0000445439

Identifier Type: -

Identifier Source: org_study_id