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Status:

UNKNOWN

Capecitabine, Panitumumab, and Radiation Therapy With or Without Irinotecan Hydrochloride in Treating Patients Undergoing Surgery for Localized Rectal Cancer

Lead Sponsor:

Loma Linda Oncology Medical Group, Inc.

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Detailed Description

OBJECTIVES: Primary * To assess the pathological tumor response rate in patients with localized rectal cancer treated with neoadjuvant chemoradiotherapy comprising capecitabine, panitumumab, and rad...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the distal rectum (0-9 cm from the dentate line or 3-12 cm from the anal verge)
  • T3 or T4 tumor or nodal involvement by endorectal ultrasound or CT scan or MRI
  • Patients with any T status where tumor is close to but not involving the sphincter who otherwise would be candidates for abdominoperineal resection are eligible
  • No known homozygotes to UGT1A1\* 28
  • No distant metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Magnesium normal
  • Able to tolerate major surgery
  • Able and willing to comply with study requirements
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks (males) or 24 weeks (females) after completion of study therapy
  • No prior diagnosis of interstitial lung disease
  • No prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
  • No other prior or concurrent invasive malignancy unless disease-free for ≥ 5 years
  • No lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets, or malabsorption syndrome
  • No concurrent serious infections
  • No clinically significant cardiovascular disease within the past year, including any of the following:
  • Myocardial infarction
  • Unstable angina
  • Symptomatic congestive heart failure
  • Symptomatic coronary artery disease
  • Serious uncontrolled cardiac arrhythmia
  • No history of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the study results
  • No known positivity for HIV, hepatitis C, or acute or chronic active hepatitis B
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or radiotherapy for rectal cancer
  • No prior anti-EGFr antibody therapy (e.g., cetuximab)
  • No prior treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
  • No prior therapeutic radiotherapy to the pelvis
  • More than 28 days since prior major surgery
  • More than 14 days since prior minor surgery
  • At least 30 days since prior investigational agent or therapy
  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • No concurrent chronic immunosuppressive agents (e.g., methotrexate or cyclosporine)
  • No concurrent cimetidine

Exclusion

    Key Trial Info

    Start Date :

    July 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    54 Patients enrolled

    Trial Details

    Trial ID

    NCT00967655

    Start Date

    July 1 2009

    Last Update

    January 10 2014

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Davood Vafai, MD, Medical Offices, Incorporated

    Redlands, California, United States, 92374

    2

    Loma Linda Oncology Medical Group, Incorporated

    Redlands, California, United States, 92374

    3

    New Hope Cancer and Research Institute - Glendora

    Redlands, California, United States, 92374

    4

    New Hope Cancer and Research Institute - Pomona

    Redlands, California, United States, 92374