Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00250835
First received: November 4, 2005
Last updated: March 3, 2014
Last verified: March 2014

November 4, 2005
March 3, 2014
April 2005
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00250835 on ClinicalTrials.gov Archive Site
Not Provided
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Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Rectal Cancer
A Phase II Trial Using a Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Patients With Newly Diagnosed Resectable Rectal Cancer

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
Other: 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.

Experimental: Chemotherapy + Radiation
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.
Intervention: Other: Oxaliplatin, Capecitabine, Celecoxib with Radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
38
December 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00250835
3304C, NCI-2011-02685
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Fa-Chyi Lee, MD University of New Mexico
New Mexico Cancer Care Alliance
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP