Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Celecoxib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed rectal adenocarcinoma

• Clinical stage T3, 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

• Tumor may not be clinically fixed

• Negative margins by routine examination of an unanesthetized patient

• 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

• No history of transient ischemic attacks or stroke

• 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 3 weeks since prior major surgery and recovered

Other

• At least 7 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin

• 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