Colorectal CancerPhase 2NCT00625183
Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
A Phase 2 study testing selenomethionine, capecitabine and oxaliplatin in people with Colorectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- selenomethionine, capecitabine and oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- selenomethionine, capecitabine, oxaliplatin, laboratory biomarker analysis, pharmacological study
- Keywords
- adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenomethionineDietary supplement
capecitabineDrug
oxaliplatinDrug
laboratory biomarker analysisOther
adjuvant therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy | Experimental | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Pathological Response Rate
Measured: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy
Measured: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Secondary outcomes (4)
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.
Measured: Adverse events were queried for and collected every cycle for the duration of treatment.
Dose Intensity
Measured: During treatment with capecitabine, oxaliplatin, selenomethionine.
Local Relapse Rate
Measured: For up to 5 years following surgery.
Distant Relapse Rate
Measured: For up to 5 years following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionDec 2009
Why it stopped: Withdrawn due to poor/low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marwan Fakih, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625183
- Sponsor's protocol ID
- I 113607
- Other IDs
- RPCI-I-113607
- Status last verified
- Oct 2017
- First submitted
- 26 Feb 2008
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00625183
- Acronym / sponsor ID
- I 113607
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to poor/low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy | Experimental | 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 therapyOxaliplatin: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenomethionine | Dietary supplement | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| capecitabine | Drug | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| oxaliplatin | Drug | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| laboratory biomarker analysis | Other | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| pharmacological study | Other | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| adjuvant therapy | Procedure or surgery | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| neoadjuvant therapy | Procedure or surgery | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| therapeutic conventional surgery | Procedure or surgery | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
| radiation therapy | Radiation | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy |
Primary outcome
Complete Pathological Response Rate
Time frame: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
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.
4 secondary outcomes
Safety and Tolerability as Assessed by NCI CTCAE Version 3.0
Time frame: Adverse events were queried for and collected every cycle for the duration of treatment.
Dose Intensity
Time frame: During treatment with capecitabine, oxaliplatin, selenomethionine.
Local Relapse Rate
Time frame: For up to 5 years following surgery.
Distant Relapse Rate
Time frame: For up to 5 years following surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan Fakih, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selenomethionine, capecitabine and oxaliplatin in people with Colorectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Pathological Response Rate (time frame: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.