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Study Summary
No. 2006-0948:.......Gastrointestinal......Chris Garrett......Gastrointestinal Medical Oncology
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Study Summary Title
Study Summary
Number:		2006-0948
Study Title:A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer
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Physician New Patient Referral
Name:Chris GarrettPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gastrointestinal Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6156
Contact us about clinical trials
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General Information
Disease Group:GastrointestinalSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Patients will need to return to Cancer Hospital 5 days a week for weeks 1-3 and
5-7.
Treatment
Agents:		HuaChanSuHome Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to compare the combination of
HuaChanSu plus gemcitabine with gemcitabine alone in the treatment of
pancreatic cancer. Researchers want to find out how the treatments affect
quality of life. Researchers will also study how HuaChanSu is absorbed,
spread, and removed from the body.
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Study Objectives / Outcomes
This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.

Primary End Point:

1. Determine the efficacy of huachansu as measured by progression free survival at 4 months.
    Secondary End Points:

    1. Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
      2. Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
        3. Monitor patient blood levels of the three main cardiac glycosides that are in huachansu (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to delineate the role of these cardiac glycosides in antitumor activity.
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        Study Status Information
        Study Activation / Registration Date:06/12/2007
        IRB Review and Approval Date:06/12/2007
        Study Type:Phase Ii Or Phase I/Ii
        Recruitment Status:Open
        Projected Accrual:80
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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) Histologically/cytologically confirmed unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.

        2) Karnofsky Performance Status > 60 (see Appendix H for definition)

        3) Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.

        4) Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.

        5) Patients must have adequate organ functions reflected by the laboratory criteria below: Granulocytes >1,500/uL; Hemoglobin >/= 8.0 gm/dL; Platelets > 100,000/uL; Serum creatinine < 2.0 mg/dL; Bilirubin < 1.5 mg/dL; SGPT < 3 x normal; Alk Phos < 3 x normal; Calcium </=11.0 mg/dL

        6) Age >/=18

        7) Patients must not have received any prior chemotherapy. Prior exposure to Traditional Chinese Medicine is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.

        8) Concomitant bisphosphonates are allowed for patients with bone metastases.

        9) Patients with jaundice must have a biliary drainage decompression operation before recruitment.

        10) Ability to understand and the willingness to sign a written informed consent.

        11) Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
        Exclusion Criteria:1) Known central nervous system involvement and leptomeningeal disease

        2) Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.

        3) Known allergies to the huachansu or toad skin products.

        4) Concurrent infection requiring intravenous antibiotics.

        5) Pregnant or lactating women.

        6) Prior treatment with systemic chemotherapy.
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        Links
        Registration Number: NCT00837239
        Study Information on Clinical Trials Registry (clinicaltrials.gov)
        Other Links:
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        Results

        Return to Clinical Trials at M.D. Anderson Cancer Center