This trial is active, not recruiting.

Condition rectal cancer
Treatment oxaliplatin, capecitabine, celecoxib with radiation
Phase phase 2
Sponsor New Mexico Cancer Care Alliance
Start date April 2005
End date December 2012
Trial size 38 participants
Trial identifier NCT00250835, 3304C, NCI-2011-02685


The primary objective is to determine the pathologic complete response rate after treatment with a combination oxaliplatin, capecitabine, celecoxib and concurrent radiation in T3-4N0-2M0 patients.

The secondary objectives are determining:

- Downstaging rate after treatment with a combination of oxaliplatin, capecitabine, celecoxib and concurrent radiation in T3-4N0-2M0 patients

- Incidence and severity of adverse events associated with a treatment combination of oxaliplatin, capecitabine, celecoxib and concurrent radiation in T3-4N0-2M0 patients.

- Incidence of sphincter-saving surgery

- 3 yr. pelvic local control rate

- 3 yr. disease-free survival

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients were treated with oxaliplatin weekly at 50 mg/m2, capecitabine on days of radiation at 850 mg/m2/PO BIC 1700 mg/m2/day, and celebrex: 200 mg orally 2/day.
oxaliplatin, capecitabine, celecoxib with radiation
Oxaliplatin: weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation. Capecitabine: on the days of radiation at 850 mg/m2/PO BID [1700 mg/m2/day] Monday through Friday during radiation therapy. Celebrex: 200 mg orally twice a day throughout the duration of radiation without a break.

Primary Outcomes

The primary endpoint is the pathologic complete response rate (pCR). Treatment toxicity and Kaplan-Meier estimates of time to progression and survival will also be determined.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients 18 years of age or older, with biopsy proven T3-4N0-2M0 rectal cancer are eligible. - life expectancy of at least 2 years. - Zubrod performance status of 0-2. - Patients must be able to sign an informed consent. - adequate bone marrow function: peripheral granulocyte count of > 1,500 cells/mm3 and platelet count >100,000/mm3, hemoglobin > 10 gm/dl and absence of a regular red blood cell transfusion requirement. - adequate hepatic function with a total serum bilirubin < 1.5 x ULN; alkaline phosphatase, ALAT, and ASAT < 2.5 x ULN; and adequate renal function as defined by a calculated creatinine clearance > 50 ml/min [Cockroft-Gault]. - other initial cancer diagnosis more than five years ago without evidence of residual or recurrent disease - prior diagnosis of squamous or basal cell carcinoma of skin,no active disease at the time of enrollment. Exclusion Criteria: - known metastases - Pregnant or lactating women. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. - may receive no other concurrent chemotherapy or radiation therapy during this trial. - severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections - Prior pelvic radiation - known active inflammatory bowel disease, Crohn's disease or ulcerative colitis. - medical conditions that would preclude the patient from definitive surgery at the end of concurrent chemoradiation - Serious, uncontrolled, concurrent infection(s). - Prior severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency. - Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer. - Participation in any investigational drug study within 4 weeks preceding the start of study treatment. - Clinically significant cardiac disease or myocardial infarction within the last 12 months. - History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. - Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. - Major surgery <4 weeks of the start of study treatment, without complete recovery. - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. - Known, existing uncontrolled coagulopathy - Any of the following laboratory values: - Abnormal hematologic values (neutrophils < 1.5 x 10^9/L, platelet count < 100 x 10^9/L, hemoglobin < 10 gm/dl) - Impaired renal function (estimated creatinine clearance <50 ml/min as calculated with Cockroft-Gault equation. - Serum total bilirubin > 1.5 x upper normal limit. - ALAT, ASAT > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases). - Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease). - Unwillingness to give written informed consent. - Unwillingness to participate or inability to comply with the protocol for the duration of the study. - History of allergic reactions, hypersensitivity reactions to aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or sulfonamides

Additional Information

Official title A Phase II Trial Using a Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Patients With Newly Diagnosed Resectable Rectal Cancer
Principal investigator Fa-Chyi Lee, MD
Description This is a single-arm Phase II trial of concurrent chemoradiation preoperatively for patients with T3-4N0-2M0 rectal cancer. Patients will be entered in a two-step Simon design.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by New Mexico Cancer Care Alliance.