Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086931
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : March 8, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and 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. Oxaliplatin and capecitabine may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and capecitabine when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for locally advanced cancer of the rectum. NOTE: *The phase I portion of this trial closed 06/2005. The best dose of oxaliplatin and capecitabine has been determined.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:



  • Determine the maximum tolerated dose of neoadjuvant oxaliplatin and capecitabine when combined with radiotherapy in patients with locally advanced adenocarcinoma of the rectum. (Phase I closed to accrual as of 06/2005.)
  • Determine the rate of complete pathological response in patients treated with this regimen.


  • Determine the overall survival of patients treated with this regimen.
  • Determine the rate of local and overall failure in patients treated with this regimen.
  • Determine the utility of TS, TP, DPD, ERCC-1, and apoptosis to predict response in patients treated with this regimen.
  • Determine the rate of pathologic down-staging in patients treated with this regimen.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine the rate of sphincter-saving rectal surgery in patients treated with this regimen who had been deemed candidates for abdominoperineal resection at diagnosis.

OUTLINE: This is a multicenter, phase I (phase I closed to accrual as of 06/2005), dose-escalation study of oxaliplatin and capecitabine followed by a phase II study.

  • Phase I (closed to accrual as of 06/2005): Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks and receive oral capecitabine twice daily on days radiotherapy is administered. Beginning on day 1 of radiotherapy, patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients undergo radiotherapy and receive capecitabine and oxaliplatin as in phase I at the MTD.

All patients undergo curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy.

Patients are followed every 3 months for 3 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 31-40 patients (6-15 for phase I [phase I closed to accrual as of 06/2005] and 25 for phase II) will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Weekly Intravenous Oxaliplatin in Combination With Oral Daily Capecitabine and Radiation Therapy in the Neoadjuvant Treatment of Rectal Cancer
Study Start Date : September 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: capecitabine
    oral dose escalating, twice daily.
  • Drug: oxaliplatin
    IV over 2 hours on days 1, 8, 15, 22, and 29.
  • Procedure: conventional surgery
    curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy
  • Procedure: neoadjuvant therapy
    chemotherapy and radiation prior to surgery
  • Radiation: radiation therapy
    once daily 5 days a week for 5.5 weeks

Primary Outcome Measures :
  1. Complete pathological response rate at time of surgery [ Time Frame: Time of surgery ]

Secondary Outcome Measures :
  1. Disease-free survival, safety, and overall survival at 5 years [ Time Frame: Continuous ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum

    • Tumor involving the distal 12 cm of the rectum (above the anal verge)
    • Clinically staged by endoscopic ultrasound with one of the following criteria:

      • T3-T4 disease
      • Evidence of lymph node involvement, defined by the presence of ≥ 1 enlarged peri-rectal lymph node (≥ 1 cm in size)
  • No known distant metastases



  • 18 to 75

Performance status

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 1 year


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Able to receive oral medication
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior or concurrent significant neuropathy
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No ongoing or active infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 3 months after study participation


Biologic therapy

  • No concurrent granulocyte-stimulating factors


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior pelvic radiotherapy


  • Not specified


  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086931

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Study Chair: Marwan Fakih, MD Roswell Park Cancer Institute

Publications of Results:
Responsible Party: Roswell Park Cancer Institute Identifier: NCT00086931     History of Changes
Other Study ID Numbers: I 10803
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the rectum
stage III rectal cancer
stage II rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents