Solid Tumor
A Phase I Study of Belinostat in Combination With Cisplatin and Etoposide in Adults With Small Cell Lung Carcinoma and Other Advanced Cancers
NCI-09-C-0173
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Investigator(s): |
Richard Piekarz, M.D., Ph.D.
Principal Investigator
Phone: 301-496-1196
rpiekarz@nih.gov
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Robin Frye, R.N., B.S.N.
Research Nurse
Phone: 301-402-5958
fryer@mail.nih.gov
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Primary Eligibility:
- Histologic or cytologic confirmation of recurrent or advanced cancer for which there is no known standard therapy capable of extending life expectancy
- Recovered from prior therapy
- ECOG performance status 0–2
- Absolute neutrophil count > 1,500/mm3
- Platelets > 100,000/mm3
- Total bilirubin < 1.2 mg/dL (except patients with Gilbert's syndrome)
- AST and ALT < 2.5 x institutional upper limit of normal (ULN)
- Creatinine < 1.5 x ULN OR creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels > ULN
- ≥ 18 years of age
- No other histone deacetylase inhibitor for ≥ 2 weeks prior to enrollment
- No history of CNS metastasis unless control has been achieved with either radiation or surgical resection ≥ 3 months prior to enrollment on study
- Patients who have had radiation to the pelvis or other bone-marrow-bearing sites considered on a case-by-case basis and may be excluded if the bone marrow reserve is not considered adequate (> 25% of bone marrow)
- No medical condition that would preclude study participation
- HIV negative
- Not pregnant or nursing
- Patients with prostate cancer may continue ongoing LhRH agonist therapy
- Patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment while on study
Study Outline:
- Belinostat 400 mg/m2/24h administered by continuous IV infusion on Days 1 and 2, cisplatin at 80 mg/m2 IV on Day 2, and etoposide at 100 mg/m2 IV daily x 3 on Days 2–4
- Dose escalation of belinostat will follow according to traditional three-patient cohorts
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed:
Updated: 8/11/09
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