The Columbia University
Velcade and Eloxatin clinical trial, located in New York City, is recruiting patients with malignant pleural
or peritoneal mesothelioma.
The study’s primary aim is to determine the objective tumor response rate for
Velcade plus Eloxatin in patients with malignant mesothelioma.
Additional
trial objectives include determining tumor response rate, median survival, time
to response, duration of response and time to treatment failure or progression
of disease. The study is also aimed at ascertaining whether in vitro assessment
of gene expression profiles via PCR can be used to gauge a patient’s response
to Velcade therapy, as well as to characterize the quantitative and qualitative
toxicities of Velcade plus Eloxatin in these patients.
The trial,
which was last updated on ClinicalTrials.gov on April 9, 2010, has an estimated
enrollment of 29 participants. The study began in September 2009 and has an
estimated completion date of September 2014.
Mesothelioma
is a type of cancer occurring in the lining of the chest or abdomen. Those who
are exposed to airborne asbestos particles are more likely to develop the
disease. It is typically treated with surgery, mesothelioma radiation,
chemotherapy or a combination of the three.
Both men and
women 18 years and older may participate in the study as long as they have
historically confirmed malignant pleural or peritoneal mesothelioma epithelial,
sarcomatoid, or mixed subtype that is not curable with surgery. Patients must
have fewer than two prior forms of systemic chemotherapy, and they must also
have the presence of at least one measurable lesion.
Voluntary and
written informed consent is required for participation in the trial, and all
recruits must have a life expectancy of at least 12 weeks. Patients must be
located within a geographic proximity to allow for follow-up, and they must
have adequate organ function at the time of the screening visit. Female
patients must be post-menopausal, surgically sterilized or willing to use an
acceptable method of birth control.
Females who
are pregnant or breastfeeding are excluded from the mesothelioma treatment trial, as are
patients who have previously been treated with Velcade or Eloxatin. Recruits
will also be excluded if they have experienced myocardial infarction within the
6 months prior to the beginning of the trial or have New York Hospital
Association Class III or IV heart failure. Any patients with serious medical or
psychiatric illnesses that could interfere with their participation in this
study will be excluded, as will those recruits with serious concomitant
systemic disorders (including oncologic emergencies) incompatible with the
study.
Patients
accepted into the trial will undergo four treatments with Velcade and two
treatments with Eloxatin during each 28-day cycle. Patients undergo physical
examinations and blood work during each visit. CT scans will be performed every
two cycles, and a Quality of Life (QOL) assessment will be performed prior to
each cycle. For
additional information, please contact: Robert Taub, M.D.
at rnt1@columbia.edu.
Mesothelioma.com,
a trusted Internet resource for information about mesothelioma cancer,
encourages patients and their family to consider enrolling in a clinical trial.
Your oncologist will be able to determine whether or not you are a good candidate
for a particular trial.
