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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT00006016 |
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Date of registration:
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05/07/2000 |
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Primary sponsor: |
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Public title:
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Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
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Scientific title:
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An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer |
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Date of first enrolment:
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May 2000 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00006016 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Alec Goldenberg |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York University Langone Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically proven hepatocellular carcinoma
- Ineligible for potentially curative surgical resection
- Must be a candidate for palliative chemoembolization
- MRI must show one or more discrete tumor nodules that can be targeted by
angiography for chemoembolization
- No diffusely infiltrating tumor
- Lesions under consideration for chemoembolization must demonstrate substantial
hypervascularity
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,200/mm^3
- Hemoglobin at least 8.0 g/dL
- Platelet count at least 50,000/mm^3
- SGOT and SGPT no greater than 5 times normal
- Bilirubin less than 3 mg/dL
- Creatinine no greater than 1.5 mg/dL
- No other medical condition that would preclude study participation
- No other malignancy within the past 5 years except curatively resected basal cell
skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Regardless of fertility status:
- All female patients (unless they have undergone a hysterectomy or have been
amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly
active method of contraception AND 1 additional effective method of
contraception at least 4 weeks before, during, and for at least 4 weeks after
study participation
- All male patients (even if they have undergone a successful vasectomy) must use
effective barrier contraception during and for at least 4 weeks after study
participation
- Prior interferon for hepatitis allowed
- No prior biologic therapy for hepatocellular carcinoma (HCC)
- No prior chemotherapy for hepatocellular carcinoma (HCC)
- No concurrent barbiturates or alcohol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult Primary Hepatocellular Carcinoma
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Advanced Adult Primary Liver Cancer
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Localized Unresectable Adult Primary Liver Cancer
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Intervention(s)
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Drug: doxorubicin hydrochloride
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Drug: thalidomide
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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Survival
[Time Frame: Up to 18 months]
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Secondary ID(s)
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CDR0000068025
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N01CM17103
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NCI-2012-02352
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NYU-9937
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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