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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00030095

2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing 2-methoxyestradiol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
2-methoxyestradiol
How many people
Not given
Where
2 sitesUnited States
Study dates
Sep 2001to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
2-methoxyestradiol
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2-methoxyestradiolDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030095
Sponsor's protocol ID
CDR0000069022
Other IDs
NCI-01-C-0256, NCI-3371, NCI-CC-01-C-0256
Status last verified
Jul 2006
First submitted
30 Jan 2002
Last updated
30 Apr 2015
Results posted
No

Publications

  • Lakhani NJ, Sarkar MA, Venitz J, Figg WD. 2-Methoxyestradiol, a promising anticancer agent. Pharmacotherapy. 2003 Feb;23(2):165-72. doi: 10.1592/phco.23.2.165.32088.

    PubMed 12587805

  • Lakhani NJ, Sparreboom A, Venitz J, et al.: Single oral dose pharmacokinetics (PK) and safety of 2-methoxyestradiol (2ME2) in patients with solid tumors. [Abstract] J Clin Oncol 23 (Suppl 16): A-2071, 152s, 2005.

  • Dahut WL, Lakhani N, Kohn EC, et al.: A phase I study of 2-methoxyestradiol (2ME2) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-833, 2003.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 2-methoxyestradiol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030095, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

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