Status:
COMPLETED
Vorinostat and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as vorin...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity, maximum tolerated dose, and pharmacokinetics of vorinostat (SAHA) and gemcitabine in patients with metastatic or unresectable epithelial s...
Eligibility Criteria
Inclusion
- ECOG 0-2 OR Karnofsky 60-100%
- AST and ALT =\< 2.5 times ULN
- Bilirubin =\< 1.5 times upper limit of normal (ULN)
- Platelet count \>= 100,000/mm3
- Absolute neutrophil count \>= 1,500/mm3
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Any number and type of prior chemotherapies are allowed including prior use of gemcitabine chemotherapy. A washout phase of at least 2 weeks since use of prior chemotherapy or radiation therapy, 6 weeks if the last regimen included nitrosoureas or mitomycin C, is required.
- Patients must have histologically confirmed epithelial malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have at least one measurable lesion as per the RECIST Criteria that can be accurately measured in at least one dimension, with minimum lesion size equal to or more than twice the slice thickness of the imaging study used.
Exclusion
- No symptomatic congestive heart failure
- No cardiac arrhythmia
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No history of allergy, significant side effects, or poor tolerance to gemcitabine
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat (SAHA)
- At least 2 weeks since prior radiotherapy
- Recovered from prior therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other uncontrolled illness
- More than 2 weeks since prior valproic acid
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00243100
Start Date
November 1 2005
Last Update
December 16 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030