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Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum Clinical research trials and Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum. Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum clinical trial. Test subjects typically receive the most expert healthcare available for their Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum  Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
For Condition: stage 3 rectal cancer,adenocarcinoma of the rectum,stage 2 rectal cancer
Status: Not yet recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combining neoadjuvant celecoxib with capecitabine and pelvicirradiation in treating patients who have stage II or stage IIIadenocarcinoma (cancer) of the rectum.
Details: OBJECTIVES: Primary - Determine the pathological complete response rate in patients with stage II or III adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in combination with pelvic irradiation. Secondary - Determine the safety and tolerability of this regimen in these patients. - Determine the rectal function of patients treated with this regimen. - Determine the time to recurrence or progression and survival time of patients treated with this regimen. - Correlate cellular and molecular markers in pretreatment tumor samples with response in patients treated with this regimen. OUTLINE: This is a multicenter study. - Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks. - Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy. - Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. 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 24-52 patients will be accrued for this study within 10-25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed rectal adenocarcinoma - Clinical stage T3, N0, M0 or T4, N0, M0 OR any T, N1-3, M0 disease - Treatment with neoadjuvant chemotherapy and pelvic radiotherapy is indicated - All disease must be encompassable within standard pelvic radiotherapy fields - Distal border of the tumor must be at or below* the peritoneal reflection, defined as within 12 cm of the anal verge by endoscopy NOTE: *If a portion of the tumor is below the peritoneal reflection at the time of surgery, patients are eligible regardless of the distance of the tumor determined at endoscopy - Tumor must be determined to be clinically resectable or not - Tumor may be clinically fixed or initially not completely resectable - Transmural penetration of tumor through the muscularis propria by CT scan, endorectal ultrasound, or MRI - No distant metastatic disease - No evidence of tumor outside the pelvis, including any of the following: - Metastatic inguinal lymphadenopathy - Peritoneal seeding - Liver metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 6 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin upper limit of normal (ULN) - AST 3 times ULN - Alkaline phosphatase 4 times ULN if AST < ULN Renal - Creatinine clearance 30 mL/min - No renal impairment Cardiovascular - No congestive heart failure - No symptomatic coronary artery disease - No uncontrolled cardiac arrhythmias - No myocardial infarction within the past 12 months - No other clinically significant cardiac disease Gastrointestinal - No bleeding peptic ulcer disease within the past 12 months - No lack of physical integrity of the upper gastrointestinal tract - No malabsorption syndrome - No active inflammatory bowel disease - Must be able to swallow study drugs Other - No dihydropyrimidine dehydrogenase deficiency - No history of uncontrolled seizures - No CNS disorders - No clinically significant psychiatric illness that would preclude study compliance or giving informed consent - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No known sensitivity to NSAIDs, sulfonamides, or aspirin - No other serious medical illness that would preclude study treatment - No other conditions that would preclude study participation - Must be able to tolerate major surgery that may include abdominal-perineal resection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 30 days after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior systemic anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the pelvis Surgery - See Disease Characteristics - More than 4 weeks since prior major surgery and recovered Other - At least 7 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs) - No other concurrent investigational drugs - No other concurrent anticancer treatment - No concurrent NSAIDs - No concurrent primary prophylactic therapy for hand-foot syndrome - No concurrent loperamide prophylaxis for diarrhea - No concurrent sorivudine or brivudine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeidiNelson, , Mayo Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000360666; NCCTG-N0346
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081224
Other Stage 3 Rectal Cancer Studies:
1. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
2. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
3. Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
4. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
5. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
Related Studies:
Other stage 3 rectal cancer Clinical Trials
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Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
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