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Status:

COMPLETED

Capecitabine and Radiation Therapy With or Without Panitumumab in Treating Patients With Advanced Rectal Cancer

Lead Sponsor:

Swiss Cancer Institute

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation t...

Detailed Description

OBJECTIVES: * To assess the efficacy and safety of neoadjuvant capecitabine and concurrent 3-dimensional conformal radiotherapy with vs without panitumumab in patients with advanced K-ras unmutated r...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal involvement
  • Stage mrT3-4 and/or mrN1-2, M0
  • Tumors must express wild type K-ras gene
  • No distant metastasis
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-1
  • Able to undergo surgery
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 100 g/L
  • Creatinine clearance ≥ 50 mL/min
  • AST ≤ 2.5 times upper limit normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use effective contraception during and for 12 months after completion of study
  • No malignancy within the past 5 years with the exception of adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
  • No psychiatric disorder that would preclude understanding study-related information, giving informed consent, or complying with oral drug intake
  • No prior existing conditions that would preclude radiotherapy
  • No clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the past 12 months
  • No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • No serious underlying medical condition that, in the judgement of the investigator, could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes)
  • No known dihydropyrimidine dehydrogenase deficiency
  • No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
  • PRIOR CONCURRENT THERAPY:
  • More than 30 days since prior treatment in a clinical trial
  • No other concurrent experimental drugs, anticancer therapy, or investigational treatments
  • No prior treatment for rectal cancer
  • No prior anti-EGFR antibody therapy (e.g., cetuximab) or small-molecule EGFR inhibitors (e.g., erlotinib hydrochloride)
  • No concurrent treatment with brivudine, lamivudine, ribavirin, or any other nucleoside analogues
  • No organ allografts
  • No concurrent drugs contraindicated for use with the trial drugs
  • No other concurrent anti-EGFR-targeting agents
  • No other concurrent radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    November 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2014

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT00814619

    Start Date

    November 1 2008

    End Date

    January 1 2014

    Last Update

    April 30 2014

    Active Locations (24)

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    Page 1 of 6 (24 locations)

    1

    Szent Laszlo Korhaz

    Budapest, Hungary, 1097

    2

    Hirslanden Klinik Aarau

    Aarau, Switzerland, CH-5001

    3

    Kantonspital Aarau

    Aarau, Switzerland, CH-5001

    4

    Kantonsspital Baden

    Baden, Switzerland, CH-5404