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2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: January 4, 2002   Last Updated: November 16, 2008   History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028821
  Purpose

RATIONALE: 2-methoxyestradiol may stop or slow the growth of solid tumors 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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Drug: 2-methoxyestradiol
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

OBJECTIVES:

  • Determine the optimal biologic dose and/or maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the pharmacokinetics and metabolism of this drug in these patients.
  • Determine the biologic changes within the tumor of these patients when treated with this drug.
  • Correlate the pharmacokinetics and toxicity of this drug in these patients.
  • Evaluate the biologic evidence of angiogenesis inhibition in patients receiving this drug.
  • Correlate genetic polymorphisms in cytochrome P450 and sulfotransferases isoforms with the pharmacokinetics of this drug.

OUTLINE: This is a dose-escalation study.

Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 42-60 patients will be accrued for this study within 19 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic:

  • Bilirubin normal
  • AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Gastrointestinal:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 4 weeks since prior biologic therapy
  • More than 4 weeks since prior immunotherapy
  • No concurrent immunotherapy

Chemotherapy:

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent megestrol

Radiotherapy:

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • No prior extensive resection of terminal small bowel
  • No prior major resection of the stomach or proximal small bowel

Other:

  • No other concurrent ancillary investigational therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028821

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Charles Erlichman, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069137, MAYO-MC0017, NCI-3356
Study First Received: January 4, 2002
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00028821     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage III multiple myeloma
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Estrogens
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Mitosis Modulators
Vascular Diseases
Antimitotic Agents
Estradiol
Pharmacologic Actions
Multiple Myeloma
Neoplasms
2-methoxyestradiol
Tubulin Modulators
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 27, 2009