2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: 2-methoxyestradiol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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: | September 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | William Dahut, MD | NCI - Medical Oncology Branch |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00030095 History of Changes |
| Obsolete Identifiers: | NCT00024609 |
| Other Study ID Numbers: | CDR0000069022, NCI-01-C-0256, NCI-3371, NCI-CC-01-C-0256 |
| Study First Received: | January 30, 2002 |
| Last Updated: | December 5, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms 2-methoxyestradiol Estradiol Angiogenesis Inhibitors Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013