Clinical trial · Interventional
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors
NCT00028821CI-TRIAL-00008946completedPhase 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)
Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-methoxyestradiol | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (2-methoxyestradiol)
- description
- Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: 2-methoxyestradiol
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0
- timeFrame
- 28 days
- description
- Presented primarily in a descriptive fashion.
- measure
- Number of toxicity incidents as assessed by CTC version 2.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL * Bilirubin normal * AST no greater than 2.5 times upper limit of normal (ULN) * Creatinine no greater than 1.5 times ULN * No New York Heart Association class III or IV heart disease * 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 * 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 * More than 4 weeks since prior biologic therapy * More than 4 weeks since prior immunotherapy * No concurrent immunotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No concurrent chemotherapy * No concurrent megestrol * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * No concurrent radiotherapy * No prior extensive resection of terminal small bowel * No prior major resection of the stomach or proximal small bowel * No other concurrent ancillary investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.