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

NCT00250835 | Terminated Phase 2 Results DMC

• 2 other identifiers: 3304CNCI-2011-02685
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

A combination of chemotherapy and radiation is often used to treat rectal cancer patients before surgery in an effort to shrink the tumor and make it easier to remove as well as to help increase the chances of sphincter-sparing surgery. Many previous clinical studies have suggested that rectal cancer patients may survive longer if the surgery results in a pathological complete response - that is, the absence of any tumor cells in the surgical specimen. However, there is still controversy over this. This study attempts to start to answer this question by treating rectal cancer patients with a combination of chemotherapy drugs (oxaliplatin and capecitabine), a cyclooxygenase-2 (COX-2) enzyme inhibitor and radiation before surgery. The rates of pathologic complete response, sphincter-sparing surgery, and disease-free survival are some of the therapeutic endpoints that will be studied.

Conditions

Rectal Cancer

Keywords

Resectable Rectal Cancer; Radiation; Neoadjuvant; Rectum; GI - Colorectal Neoadjuvant; Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (PCR)

  The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes.

  At surgery (up to 6 weeks after end of treatment)

Secondary Outcomes (5)

• Toxicity

  Up to 3 years

• Progression-free Survival (PFS)

  3 years after surgery

• Incidence of Sphincter-sparing Surgery

  At surgery (up to 6 weeks after end of treatment)

• Surgical Downstaging Rate

  At surgery (up to 6 weeks after treatment)

• Pelvic Local Control Rate

  Up to 3 years after surgery

Study Arms (1)

Chemotherapy, Celecoxib, and Radiation

EXPERIMENTAL

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 orally twice a day \[1700 mg/m2/day\] (Monday through Friday during radiation therapy). Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.

Other: Chemotherapy, Celecoxib, and Radiation

Interventions

Chemotherapy, Celecoxib, and Radiation OTHER

Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment.

Also known as: Celecoxib = Celebrex, Oxaliplatin = Eloxatin, Capecitabine = Xeloda

Chemotherapy, Celecoxib, and Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, alanine aminotransferase (ALAT), and aspartate aminotransferase (ASAT) \< 2.5 x the upper limit of normal (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (3)

Hematology Oncology Associates

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

Related Publications (1)

• Araujo-Mino EP, Patt YZ, Murray-Krezan C, Hanson JA, Bansal P, Liem BJ, Rajput A, Fekrazad MH, Heywood G, Lee FC. Phase II Trial Using a Combination of Oxaliplatin, Capecitabine, and Celecoxib with Concurrent Radiation for Newly Diagnosed Resectable Rectal Cancer. Oncologist. 2018 Jan;23(1):2-e5. doi: 10.1634/theoncologist.2017-0474. Epub 2017 Nov 20.

  PMID: 29158365 RESULT

Related Links

• University of New Mexico Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms

Interventions

Drug Therapy; Celecoxib; Radiation; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Fa-Chyi Lee, MD
• Organization: University of New Mexico

flee@salud.unm.edu

5059250405

Study Officials

• Fa-Chyi Lee, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2015
• Last Updated: September 1, 2015
• Results First Posted: September 1, 2015

Record last verified: 2015-08

Locations

US (3)