Status:
COMPLETED
Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 v...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of decitabine and valproic acid in patients with non-small cell lung cancer. II. Determine the recommended phase II dose of this regimen ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction to compounds of similar chemical or biological composition to decitabine, valproic acid, or other study agents
- No other concurrent uncontrolled illness
- No ongoing or active infection requiring antibiotics
- No history of seizures requiring anticonvulsants
- No medical problem that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
- No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or epoetin alfa)
- No more than 3 prior chemotherapy regimens
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior definitive radiotherapy to the chest allowed
- Clinical (radiographic or other) evidence of tumor progression for previously irradiated indicator lesion in the chest
- More than 2 weeks since prior radiotherapy and recovered
- No concurrent palliative radiotherapy
- Prior curative or palliative intent surgery allowed
- At least 2 weeks since prior surgery and recovered
- At least 4 weeks since prior photodynamic therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies
- No other concurrent investigational agents
- No concurrent administration of any of the following medications:
- Aspirin
- Chronic low-dose (=\< 81 mg/day) aspirin allowed
- Felbamate
- Rifampin
- Amitriptyline
- Nortriptyline
- Carbamazepine
- Clonazepam
- Diazepam
- Ethosuximide
- Lamotrigine
- Phenobarbital
- Barbiturates
- Primidone
- Phenytoin
- Zidovudine
- No concurrent divalproex sodium
- Concurrent gabapentin for neuropathic pain allowed
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00084981
Start Date
April 1 2004
Last Update
September 30 2013
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210