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

NCT00625183 | Terminated Phase 2 Results

• 2 other identifiers: I 113607RPCI-I-113607
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

• 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.

Study Arms (1)

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

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

Interventions

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

Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy

neoadjuvant therapy PROCEDURE

Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy

therapeutic conventional surgery PROCEDURE

Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy

radiation therapy RADIATION

Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Selenomethionine; Capecitabine; Oxaliplatin; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Organoselenium Compounds; Organic Chemicals; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Combined Modality Therapy; Therapeutics; Drug Therapy

Limitations and Caveats

Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: February 28, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 17, 2017
• Results First Posted: September 26, 2014

Record last verified: 2017-10

Locations

US (1)