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2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00030095   Information provided by National Cancer Institute (NCI)
First Received: January 30, 2002   Last Updated: December 13, 2008   History of Changes

January 30, 2002
December 13, 2008
September 2001
 
 
 
Complete list of historical versions of study NCT00030095 on ClinicalTrials.gov Archive Site
 
 
 
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors

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.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: 2-methoxyestradiol
 
Lakhani NJ, Sarkar MA, Venitz J, Figg WD. 2-Methoxyestradiol, a promising anticancer agent. Pharmacotherapy. 2003 Feb;23(2):165-72. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030095
 
CDR0000069022, NCI-01-C-0256, NCI-3371, NCI-CC-01-C-0256
National Cancer Institute (NCI)
 
Study Chair: William Dahut, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP