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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081224 |
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma (cancer) of the rectum.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: capecitabine Drug: celecoxib Procedure: adjuvant therapy Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Of Celecoxib (Celebrex) And Capecitabine (Xeloda) Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum |
Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Treatment repeats every 21 days for up to 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 10-28 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed rectal adenocarcinoma
Treatment with neoadjuvant chemotherapy and pelvic radiotherapy is indicated
Tumor must be determined to be clinically resectable
No distant metastatic disease
No evidence of tumor outside the pelvis, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Frank Sinicrope, MD | Mayo Clinic |
Investigator: | James A. Martenson, MD | Mayo Clinic |
Investigator: | Richard L. Deming, MD | Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines |
Investigator: | Heidi Nelson, MD | Mayo Clinic |
Investigator: | James D. Bearden, MD | CCOP - Upstate Carolina |
Study ID Numbers: | CDR0000360666, NCCTG-N0346 |
Study First Received: | April 7, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00081224 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the rectum stage II rectal cancer stage III rectal cancer |
Antimetabolites Anti-Inflammatory Agents Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Rectal Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Capecitabine Digestive System Neoplasms Celecoxib Cyclooxygenase Inhibitors Rectal Neoplasm |
Adjuvants, Immunologic Intestinal Diseases Intestinal Neoplasms Carcinoma Digestive System Diseases Rectal Cancer Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Adenocarcinoma Antirheumatic Agents Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Capecitabine |
Digestive System Neoplasms Neoplasms by Histologic Type Celecoxib Cyclooxygenase Inhibitors Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents |