Clinical trial · Interventional
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
NCT00030095CI-TRIAL-00017739completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-methoxyestradiol | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLakhani 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. PMID 12587805
- RESULTLakhani 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.
- RESULTDahut 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.