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2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00030095
Collaborator
(none)
2
Locations

Study Details

Study Description

Brief Summary

RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.

  • Determine the side effect profile of this drug in these patients.

  • Determine the pharmacokinetic profile of this drug in these patients.

  • Determine the changes in positron-emission tomography scans of patients treated with this drug.

  • Determine the changes in apotosis in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at day 30.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors
Study Start Date :
Sep 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed solid tumor

    • Metastatic or unresectable disease for which standard curative treatments do not exist or are no longer effective

    • Clinically progressive disease documented by any of the following:

    • New area of malignant disease

    • Progression of soft-tissue metastases

    • At least 1 new metastatic deposit on technetium Tc 99m bone scintigraphy

    • Increases in prostate-specific antigen

    • Lesions accessible for serial biopsy

    • No known brain metastases

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:

    • ECOG 0-2 OR

    • Karnofsky 60-100%

    Life expectancy:
    • More than 3 months
    Hematopoietic:

    • WBC at least 3,000/mm^3

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin normal

    • AST/ALT no greater than 2.5 times upper limit of normal

    Renal:

    • Creatinine normal OR

    • Creatinine clearance at least 60 mL/min

    Cardiovascular:

    • No symptomatic congestive heart failure

    • No unstable angina pectoris

    • No cardiac arrhythmia

    Other:

    • No other concurrent uncontrolled illness

    • No ongoing or active infection

    • No prior allergic reactions to compounds of similar chemical or biological composition to 2-methoxyestradiol

    • No psychiatric illness or social situation that would preclude study compliance

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study participation

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • At least 4 weeks since prior biologic therapy
    Chemotherapy:

    • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin)

    • No concurrent chemotherapy for cancer

    Endocrine therapy:
    • Luteinizing-hormone releasing-hormone agonist therapy must be continued for patients with prostate cancer except those with prior orchiectomy
    Radiotherapy:

    • At least 4 weeks since prior radiotherapy

    • No concurrent radiotherapy for cancer

    Surgery:
    • See Endocrine therapy
    Other:

    • Recovered from prior therapy

    • No other concurrent therapy for cancer

    • No concurrent combination antiretroviral therapy for HIV-positive patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland United States 20892-1182
    2 NCI - Center for Cancer Research Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: William Dahut, MD, NCI - Medical Oncology Branch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00030095
    Other Study ID Numbers:
    • CDR0000069022
    • NCI-01-C-0256
    • NCI-3371
    • NCI-CC-01-C-0256
    • NCT00024609
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Jul 1, 2006
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    2-Methoxyestradiol

    Study Results

    No Results Posted as of Apr 30, 2015