Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00028821
Other study ID # NCI-2012-02439
Secondary ID MC0017U01CA06991
Status Completed
Phase Phase 1
First received January 4, 2002
Last updated January 15, 2013
Start date January 2002

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Description:

PRIMARY OBJECTIVES:

I. Determine the optimal biologic dose and/or maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.

II. Determine the qualitative and quantitative toxic effects of this drug in these patients.

III. Determine the pharmacokinetics and metabolism of this drug in these patients.

IV. Determine the biologic changes within the tumor of these patients when treated with this drug.

V. Correlate the pharmacokinetics and toxicity of this drug in these patients. VI. Evaluate the biologic evidence of angiogenesis inhibition in patients receiving this drug.

VII. Correlate genetic polymorphisms in cytochrome P450 and sulfotransferases isoforms with the pharmacokinetics of this drug.

OUTLINE: This is a dose-escalation study.

Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 2-ME until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 42-60 patients will be accrued for this study within 19 months.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
2-methoxyestradiol
Given orally
Other:
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0 Presented primarily in a descriptive fashion. 28 days Yes
Primary Number of toxicity incidents as assessed by CTC version 2.0 Frequency distributions and other descriptive measures will form the basis of the analysis of these variables. Up to 3 months after completion of treatment Yes
Secondary Biologic activity rate (BAR) A rate will be calculated by dividing the number of patients with BA by the number of patients treated at the phase II recommended dose level. At day 1 and at day 28 No
Secondary Angiogenesis inhibition via an ex vivo angiogenesis assay The relationship between each marker and dose level will be explored descriptively. At day 1 and at day 28 No
Secondary Number of responses Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. Up to 3 months after completion of treatment No
See also
  Status Clinical Trial Phase
Completed NCT01828775 - Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment N/A
Terminated NCT01642342 - Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors Phase 1
Completed NCT00002950 - Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer Phase 1/Phase 2
Completed NCT01705548 - Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis N/A
Completed NCT02146222 - VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors Phase 1
Terminated NCT01602627 - Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies Phase 1
Completed NCT01191216 - 1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors Phase 1
Recruiting NCT00992303 - Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
Recruiting NCT01137825 - Registry of Older Patients With Cancer
Completed NCT00924651 - Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy Phase 3
Completed NCT00949949 - Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy Phase 1
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
Withdrawn NCT00937417 - S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00573690 - Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors Phase 1
Completed NCT00544596 - R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer Phase 1
Active, not recruiting NCT00436735 - Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors Phase 1
Completed NCT00352443 - S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma Phase 1
Completed NCT00128622 - Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer Phase 1
Completed NCT00121277 - Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors Phase 1