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

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00625183

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine Drug: oxaliplatin Drug: selenomethionine Procedure: adjuvant therapy Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: pharmacological study Procedure: radiation therapy Procedure: therapeutic conventional surgery	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Capecitabine Oxaliplatin Selenomethionine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete pathological response rate [ Designated as safety issue: No ]
Rate of T-downstaging with capecitabine, oxaliplatin, selenomethionine, and radiotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
Dose intensity [ Designated as safety issue: No ]
Local relapse rate [ Designated as safety issue: No ]
Distant relapse rate [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	March 2008
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625183

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Marwan Fakih, MD

Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Roswell Park Cancer Institute ( Marwan Fakih )
Study ID Numbers:	CDR0000587793, RPCI-I-113607
Study First Received:	February 26, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00625183
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the rectum
stage II rectal cancer
stage III rectal cancer

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm

Carcinoma
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009