Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase 1 Study of Paclitaxel and Carboplatin in Solid Tumors (With Focus on Upper Aerodigestive Cancers) in Persons With HIV Infection
This phase I clinical trial is studying the side effects and the best dose of vorinostat when
given together with paclitaxel and carboplatin in treating patients with metastatic or
recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop
the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used
in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
vorinostat together with paclitaxel and carboplatin may kill more tumor cells.
NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this
specific patient population as of February 1, 2013. No patients remain on vorinostat. Going
forward this study will determine the safety and tolerability of the paclitaxel and
carboplatin combination in this patient population.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of vorinostat in combination with paclitaxel and
carboplatin in solid tumor patients with HIV infection.
II. To determine the maximal tolerated dose (MTD) of the combination in this patient
population.
*NOTE: An administrative decision was made by Cancer Therapy Evaluation Program (CTEP) to
halt further study of vorinostat in this specific patient population as of February 1, 2013,
and no patients remain on vorinostat. The primary objective going forward will determine the
safety and tolerability of the paclitaxel and carboplatin combination in this patient
population.
SECONDARY OBJECTIVES:
I. To preliminarily assess response rates of the therapeutic combination in lung, head and
neck, and esophageal cancers.
II. To evaluate the pathological characteristics of non-acquired immunodeficiency syndrome
(AIDS) defining cancers of the upper aerodigestive tract.
III. To determine the presence and oncogenic activity of human papillomavirus (HPV) infection
in tumor tissues and to correlate HPV infection with clinical outcomes.
IV. To investigate possible pharmacokinetic interactions between paclitaxel and
antiretroviral therapy in persons with HIV infection.
OUTLINE: This is a multicenter, dose-escalation study of vorinostat followed by an expansion
cohort study.
Patients receive vorinostat orally (PO) once daily on days 1-5 and paclitaxel intravenously
(IV) over 3 hours and carboplatin IV over 30 minutes on day 3. Treatment repeats every 21
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Some patients undergo blood sample collection at baseline and periodically during course 1
for pharmacokinetic studies and HIV viral load analysis.
Note: An administrative decision was made by CTEP to halt further study of vorinostat in this
specific patient population as of February 1, 2013. No patients remain on vorinostat. The
primary objective going forward will determine the safety and tolerability of the paclitaxel
and carboplatin combination in this patient population, without vorinostat. The information
pertaining to vorinostat is for historical purposes.
After completion of study therapy, patients are followed up every 6 months for up to 3 years.
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