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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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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



- 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.


- 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

- 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 23-55 patients will be accrued for this study within 10-28

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 6 months


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ upper limit of normal (ULN)

- AST ≤ 3 times ULN

- Alkaline phosphatase ≤ 4 times ULN if AST < ULN


- Creatinine clearance ≥ 30 mL/min

- No renal impairment


- 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


- 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


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

- No prior systemic anticancer chemotherapy

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior radiotherapy to the pelvis


- See Disease Characteristics

- More than 3 weeks since prior major surgery and recovered


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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of successes

Safety Issue:


Principal Investigator

Frank Sinicrope, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the rectum
  • stage II rectal cancer
  • stage III rectal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Rectal Neoplasms