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Study Summary
No. 2005-0092:.......Anus; Breast; Cervix; Colon; Colorectal; Endocrine; Endometrial; Gallbladder; Gastric; Gastrointestinal; Genitourinary; Gynecology; Liver; Melanoma; Ovary; Pancreas; Pediatrics; Phase I Studies; Rectum; Solid Tumors; Unknown Primary; Uterus; Vulva......Apostolia M. Tsimberidou......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:		2005-0092
Study Title:Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer And Dominant Liver Involvement
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Physician New Patient Referral
Name:Apostolia M. TsimberidouPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1930
Contact us about clinical trials
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General Information
Disease Group:Anus
Breast
Cervix
Colon
Colorectal
Endocrine
Endometrial
Gallbladder
Gastric
Gastrointestinal
Genitourinary
Gynecology
Liver
Melanoma
Ovary
Pancreas
Pediatrics
Phase I Studies
Rectum
Solid Tumors
Unknown Primary
Uterus
Vulva		Supported By:N/A
Phase of Study:Phase IReturn
Visit:		Patients will return to MDACC for a clinical evaluation on a bi-monthly basis
Treatment
Agents:		PaclitaxelHome Care:Home care if needed is expected to be purely supportive.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Patients will be admitted, on each cycle, for approximately 3-5 days until
recovery from all immediate treatment related toxicities
Description/
Intervention:		The goal of this clinical research study is find the highest tolerated dose of
paclitaxel that can be given directly into the liver of patients with advanced
cancer involving the liver. Researchers also want to collect descriptive
information on any effects the drug may have on tumor tissue.
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Study Objectives / Outcomes
PRIMARY
· To determine the toxicity and safety of a monthly cytotoxic regimen of intra-arterial hepatic paclitaxel in patients with cancer metastatic to the liver.
    SECONDARY
    • To document in a descriptive fashion the antitumor efficacy of monthly hepatic intra-arterial paclitaxel.
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    Study Status Information
    Study Activation / Registration Date:10/17/2005
    IRB Review and Approval Date:07/20/2005
    Study Type:Therapeutic
    Recruitment Status:Terminated
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis.

    2) Performance status ECOG < or = 2 (Requires occasional assistance but is able to care for own needs).

    3) Adequate renal function (serum creatinine < 2.0 mg/dL).

    4) Adequate hepatic function (Total bilirubin < 2.0 mg/dL; ALT </= 5 times upper normal reference value).

    5) Bone marrow function (ANC >or =1.5 cells/mcL; PLT > or = 100,000 cells/mcL).

    6) At least three weeks from previous cytotoxic chemotherapy before day 1 of HAI infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter.

    7) Ability to fully read, comprehend, and sign informed consent forms.

    8) All females in childbearing age must have a negative urine or serum HCG test unless prior hysterectomy or menopause. Women of childbearing potential and men must use effective birth control.

    9) Patients should be refractory to standard chemotherapy or have no conventional therapy that produces a CR rate of at least 10% or an increase in survival of at least three months.

    10) Patients of both genders, 13 year-old or older.
    Exclusion Criteria:1) Clinical or radiographic evidence of ascites.

    2) Pregnant or breastfeeding females.

    3) Hypersensitivity to paclitaxel compounds.

    4) History of severe hypersensitivity reactions to products containing polyoxyethylated castor oil or Cremophor.

    5) Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.

    6) Untreatable bleeding diathesis.

    7) Portal vein thrombosis.

    8) Peripheral neuropathy > Grade 1 according to NCI CTC v.3.0: sensory alteration not interfering with function).

    9) Untreated (radiation therapy, chemotherapy, surgery or a combination of modalities) brain metastasis.
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    Links
    Registration Number: NCT00508326
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

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