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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
celecoxib
irinotecan hydrochloride
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Outcomes

Primary Outcome Measures

Response rate by RECIST criteria at every other course

Secondary Outcome Measures

Time to progression
Toxicity
Overall survival
Time to treatment failure

Full Information

First Posted
November 22, 2005
Last Updated
April 5, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00258232
Brief Title
Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Official Title
Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Response rate by RECIST criteria at every other course
Secondary Outcome Measure Information:
Title
Time to progression
Title
Toxicity
Title
Overall survival
Title
Time to treatment failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A. Philip, MD, PhD, FRCP
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
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Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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