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A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma

Phase 2
18 Years
75 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma



- 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.


- 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.

Inclusion Criteria


- 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


- 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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathological response rate

Safety Issue:


Principal Investigator

Marwan Fakih, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 113607



Start Date:

March 2008

Completion Date:

December 2009

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the rectum
  • stage II rectal cancer
  • stage III rectal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Rectal Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263