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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00030615
Other study ID # NCI-2012-02727
Secondary ID OC-01-01U01CA062
Status Completed
Phase Phase 1
First received February 14, 2002
Last updated February 6, 2013
Start date December 2001

Study information

Verified date February 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

This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die


Description:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.

II. Determine the toxic effects of this drug in these patients. III. Determine the dose of this drug with biologic activity in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine clinical response to this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine 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.

Patients are followed at 2 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:

- Stage III or IV melanoma

- Mucosal melanoma allowed

- No resectable stage III melanoma

- Bladder cancer

- Breast cancer

- No active symptomatic CNS disease

- No radiographically evident cerebral edema

- Hormone receptor status:

- Not specified

- Male or female

- Performance status - ECOG 0-1

- Hemoglobin at least 9.0 g/dL

- Platelet count at least 100,000/mm^3

- WBC at least 3,500/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- No coagulation disorders

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT and SGPT less than 2.5 times ULN

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

- Creatinine no greater than 1.5 times ULN

- No major cardiovascular system illness

- No major respiratory system illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No major systemic infection

- At least 1 month since prior radiotherapy

- At least 1 month since any prior anticancer therapy or adjuvant therapy

- No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy

Study Design

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


Intervention

Drug:
decitabine
Given IV
Other:
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States University of Southern California Los Angeles California

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 determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria 6 weeks Yes
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