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Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
selenomethionine
capecitabine
oxaliplatin
laboratory biomarker analysis
pharmacological study
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery
radiation therapy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed rectal adenocarcinoma that is involving the distal 12 cm of the rectum (above the anal verge)

    • Staged within 8 weeks prior to initiation of study by endoscopic ultrasound OR MRI or CT scan if endorectal ultrasound is non-conclusive or non-tolerable
    • T3-T4 tumor or evidence of lymph node involvement defined by the presence of at least 1 enlarged peri-rectal lymph node
  • No evidence of distant or known metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy > 1 year
  • Leukocytes ≥ 3,000/µL
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelet count ≥ 100,000/µL
  • Total bilirubin ≤ upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN
  • Creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min
  • Able to receive oral medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent or previous malignancies unless disease free for > 5 years (excluding nonmelanoma skin cancer)
  • No neuropathy ≥ grade 2
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or selenomethionine

  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the pelvis
  • No prior chemotherapy
  • No other concurrent investigational or anticancer agents or therapies
  • No concurrent vitamin B6 supplementation (except as part of a standard, multivitamin supplement)

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy

Arm Description

Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends

Outcomes

Primary Outcome Measures

Complete Pathological Response Rate
Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy

Secondary Outcome Measures

Safety and Tolerability as Assessed by NCI CTCAE Version 3.0
Number of participants with any adverse event as assessed by NCI CTCAE version 3.0.
Dose Intensity
Local Relapse Rate
Distant Relapse Rate

Full Information

First Posted
February 26, 2008
Last Updated
October 13, 2017
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00625183
Brief Title
Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
Official Title
A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to poor/low accrual
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With selenomethionine and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well selenomethionine works when given together with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery for newly diagnosed stage II or stage III rectal cancer.
Detailed Description
OBJECTIVES: Primary To determine the complete pathological response rate of the combination of capecitabine, oxaliplatin, selenomethionine, and radiotherapy in patients with stage II or III rectal adenocarcinoma. To determine the T-downstaging rate with this regimen in patients with stage II or III rectal adenocarcinoma. Secondary To determine the safety of this regimen by assessing toxicity and dose intensity of the various components of this regimen. To determine the rate of local relapse. To determine the rate of distant relapse. OUTLINE: Patients receive neoadjuvant therapy comprising oral selenomethionine twice daily for 1 week prior to radiotherapy and then once daily for 6 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1-7 and oral capecitabine twice daily on days 1-5 for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks after completion of neoadjuvant therapy, patients undergo curative-intent surgery. Beginning 4-8 weeks after surgery, patients may receive up to 9 courses of standard adjuvant combination chemotherapy (FOLFOX). Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration. Pharmacokinetic studies are also performed. After completion of study treatment, patients are followed for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Arm Type
Experimental
Arm Description
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
Intervention Type
Dietary Supplement
Intervention Name(s)
selenomethionine
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Complete Pathological Response Rate
Time Frame
After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Title
Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy
Time Frame
After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Secondary Outcome Measure Information:
Title
Safety and Tolerability as Assessed by NCI CTCAE Version 3.0
Description
Number of participants with any adverse event as assessed by NCI CTCAE version 3.0.
Time Frame
Adverse events were queried for and collected every cycle for the duration of treatment.
Title
Dose Intensity
Time Frame
During treatment with capecitabine, oxaliplatin, selenomethionine.
Title
Local Relapse Rate
Time Frame
For up to 5 years following surgery.
Title
Distant Relapse Rate
Time Frame
For up to 5 years following surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed rectal adenocarcinoma that is involving the distal 12 cm of the rectum (above the anal verge) Staged within 8 weeks prior to initiation of study by endoscopic ultrasound OR MRI or CT scan if endorectal ultrasound is non-conclusive or non-tolerable T3-T4 tumor or evidence of lymph node involvement defined by the presence of at least 1 enlarged peri-rectal lymph node No evidence of distant or known metastases PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% Life expectancy > 1 year Leukocytes ≥ 3,000/µL Absolute neutrophil count ≥ 1,500/µL Platelet count ≥ 100,000/µL Total bilirubin ≤ upper limit of normal (ULN) AST/ALT ≤ 2.5 times ULN Creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min Able to receive oral medication Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent or previous malignancies unless disease free for > 5 years (excluding nonmelanoma skin cancer) No neuropathy ≥ grade 2 No history of allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or selenomethionine No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: No prior radiotherapy to the pelvis No prior chemotherapy No other concurrent investigational or anticancer agents or therapies No concurrent vitamin B6 supplementation (except as part of a standard, multivitamin supplement)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwan Fakih, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma

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