Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors
Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor
Status | Completed |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed solid tumor that is clinically unresectable - No known standard therapy that is potentially curative or definitely capable of extending life expectancy - Patients with multiple myeloma may be enrolled to expansion cohort once the recommended phase II dose is established - Tumor amenable to serial biopsy - No bone metastases as only site of disease - No CNS metastases - Performance status - ECOG 0-2 - At least 12 weeks - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL - Bilirubin normal - AST no greater than 2.5 times upper limit of normal (ULN) - Creatinine no greater than 1.5 times ULN - No New York Heart Association class III or IV heart disease - Adequate oral intake - No malabsorption syndrome - No disease of terminal small bowel - No dysphagia or other condition that would interfere with ability to swallow intact capsules - No clinical contraindications (e.g., anticoagulant therapy) to biopsy - No uncontrolled infection - No seizure disorder - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No concurrent immunotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No concurrent chemotherapy - No concurrent megestrol - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No concurrent radiotherapy - No prior extensive resection of terminal small bowel - No prior major resection of the stomach or proximal small bowel - No other concurrent ancillary investigational therapy |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0 | Presented primarily in a descriptive fashion. | 28 days | Yes |
Primary | Number of toxicity incidents as assessed by CTC version 2.0 | Frequency distributions and other descriptive measures will form the basis of the analysis of these variables. | Up to 3 months after completion of treatment | Yes |
Secondary | Biologic activity rate (BAR) | A rate will be calculated by dividing the number of patients with BA by the number of patients treated at the phase II recommended dose level. | At day 1 and at day 28 | No |
Secondary | Angiogenesis inhibition via an ex vivo angiogenesis assay | The relationship between each marker and dose level will be explored descriptively. | At day 1 and at day 28 | No |
Secondary | Number of responses | Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. | Up to 3 months after completion of treatment | No |
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