Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer
A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With Non-Small Cell Lung Cancer
8 other identifiers
interventional
25
1 country
1
Brief Summary
This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with non-small cell lung cancer. Drugs used in chemotherapy, such as decitabine and valproic acid, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedSeptember 30, 2013
September 1, 2013
8.8 years
June 10, 2004
September 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
MTD, defined as dose in which fewer than 1/3 or 2/6 patients experience DLT
28 days
Study Arms (1)
Treatment (decitabine, valproic acid)
EXPERIMENTALPatients receive decitabine IV over 1 hour on days 1-10 and oral valproic acid three times daily on days 5-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine and valproic acid until the 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. After the MTD is determined, an additional 6 patients are treated at that dose.
Interventions
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed non-small cell lung cancer
- Tumor accessible to biopsy by bronchoscopy, through surface biopsy (e.g., skin punch biopsy for skin/subcutaneous metastasis) or through CT scan guidance
- Not eligible for curative surgery, chemotherapy, radiotherapy, or multimodality treatment options
- No uncontrolled brain metastases
- Controlled brain metastases allowed provided patient has no neurologic deterioration when off steroids; has completed prior radiotherapy or other treatments; has fully recovered from prior treatment; and does not require anticonvulsants
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- WBC \> 3,000/mm\^3
- AST and ALT =\< 2.5 times upper limit of normal (ULN)
- Bilirubin =\< 1.5 times ULN
- Creatinine =\< 1.5 times ULN
- Creatinine clearance \>= 60 mL/min
- +45 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Otterson
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
April 1, 2004
Primary Completion
February 1, 2013
Last Updated
September 30, 2013
Record last verified: 2013-09