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

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: selenomethionine; Drug: capecitabine; Drug: oxaliplatin; Other: laboratory biomarker analysis; Other: pharmacological study; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy

• Registration Number: NCT00625183
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-28
• Study Start: 2008-03
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Results First Submitted: 2014-09-19
• Results First Submitted QC: 2014-09-19
• Results First Posted: 2014-09-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	capecitabine	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	oxaliplatin	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	laboratory biomarker analysis	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	selenomethionine	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	pharmacological study	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	adjuvant therapy	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	neoadjuvant therapy	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	therapeutic conventional surgery	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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy	radiation therapy	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

Primary Outcome Measures

Name	Time	Method
Complete Pathological Response Rate	After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy	After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.

Secondary Outcome Measures

Name	Time	Method
Dose Intensity	During treatment with capecitabine, oxaliplatin, selenomethionine.
Local Relapse Rate	For up to 5 years following surgery.
Distant Relapse Rate	For up to 5 years following surgery.
Safety and Tolerability as Assessed by NCI CTCAE Version 3.0	Adverse events were queried for and collected every cycle for the duration of treatment.	Number of participants with any adverse event as assessed by NCI CTCAE version 3.0.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States