Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT00258232 |
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Recruitment Status :
Completed
First Posted : November 24, 2005
Last Update Posted : April 8, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: capecitabine Drug: celecoxib Drug: irinotecan hydrochloride | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer |
| Study Start Date : | January 2002 |
| Actual Primary Completion Date : | March 2007 |
| Actual Study Completion Date : | August 2007 |
- Response rate by RECIST criteria at every other course
- Time to progression
- Toxicity
- Overall survival
- Time to treatment failure
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed adenocarcinoma of the colon or rectum
- Locally recurrent or metastatic disease
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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
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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
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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
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No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following:
- Rofecoxib
- Ibuprofen
- Naproxen
- Etodolac
- Oxaprozin
- Diflunisal
- Nabumetone
- Tolmetin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258232
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0944 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Principal Investigator: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00258232 |
| Other Study ID Numbers: |
CDR0000445439 P30CA022453 ( U.S. NIH Grant/Contract ) WSU-C-2424 |
| First Posted: | November 24, 2005 Key Record Dates |
| Last Update Posted: | April 8, 2013 |
| Last Verified: | April 2013 |
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adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer |
recurrent rectal cancer stage IV colon cancer stage IV rectal cancer |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Celecoxib Capecitabine Irinotecan Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors |