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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Capecitabine; Celecoxib; Irinotecan

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