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A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma

The primary objective of this study is to determine the objective tumor response rate for
VELCADE plus ELOXATIN in patients with malignant mesothelioma.

The aims of this study are to: (a)to determine the tumor response rate, median survival,
time to response, duration of response and time to treatment failure or progression of
disease;(b)to ascertain if in vitro assessment of gene expression profiles via PCR can be
used to ascertain a patient's response to VELCADE (bortezomib) therapy (c) to characterize
the quantitative and qualitative toxicities of VELCADE plus ELOXATIN in this patient

Each cycle of treatment is composed of 28 days and consists of four treatments with VELCADE
(d 1,4,15,and 18) and two treatments with ELOXATIN (days 4,and 18). Patients will undergo a
physical examination and routine blood work at each visit. A Quality of Life (QOL)
assessment will be performed prior to initiating each cycle of therapy and CT scans will be
performed at baseline and every 2 cycles (8 weeks)to assess tumor response.

Inclusion Criteria:

- Patients must have histologically confirmed malignant pleural or peritoneal
mesothelioma epithelial, sarcomatoid, or mixed subtype, not amenable to curative
treatment with surgery. Patients with pleural mesothelioma will be clinically staged
using the IMIG's staging criteria (section 17.1). Note that there is no staging
system for peritoneal mesothelioma and those patients will only be followed for
survival. Patients may be entered based on local pathology.

- Patients must have had ≤2 prior form of systemic chemotherapy. Prior intracavitary
chemotherapy will be considered a prior regimen unless it was given for the purpose
of pleurodesis. Immunomodulators will not be regarded as chemotherapy. Prior systemic
treatment with pemetrexed plus cisplatin or carboplatin will not be a
contraindication for treatment with VELCADE/ELOXATIN.

- Disease status must be that of measurable disease as defined by modified SWOG

Measurable disease: The presence of at least one measurable lesion. If only one lesion is
present, the neoplastic nature of the disease site should be confirmed by histology.

Measurable lesions: Lesions that can be accurately measured in at least one dimension with
the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scans.
At least one level must have one rind measurement ≥15 mm. CT (specifically spiral CT)
scans and MRI are the preferred methods of measurement.

Clinically detected lesions will only be considered measurable when they are superficial
(e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation
by color photography, including a ruler to estimate the size of the lesion is required.
NOTE: Neither pleural effusions nor positive bone scans are considered measurable.

- Patients may have undergone pleurodesis. If pleurodesis was recently performed, there
must be at a minimum of a 2 week delay prior to treatment initiation. If a CT scan
was done prior pleurodesis, a repeat CT scan for baseline evaluation will need to be
performed prior to study entry. NOTE: For patients with clinically significant
pleural effusions or ascites, consideration should be given to draining the fluid
prior to initiating therapy.

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0, 1, or 2 (after any palliative measures including pleural drainage have occurred),
see section 14.2.

- Patients must have an estimated life expectancy of at least 12 weeks.

- Patient assurance of study compliance and geographic proximity that allows for
adequate follow-up.

- Patients must have adequate organ function at the screening visit as defined by the
following laboratory values: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet
count ≥100 x 109/L Hemoglobin ≥9 g/dL. Albumin ≥ 2.5 g/dL Total Bilirubin ≤2.5 x ULN
Alkaline phosphatase ≤3.0 x ULN Aspartate transaminase (AST) and alanine transaminase
(ALT) ≤3.0 x ULN Creatinine ≤ 1.5 x ULN NOTE: total bilirubin, alkaline phosphatase,
AST, ALT ≤5 x ULN acceptable if liver has tumor involvement

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

- Patient must be a male or female of at least 18 years of age.

- Female subjects must either post-menopausal or surgically sterilized or willing to
use an acceptable method of birth control (i.e., a hormonal contraceptive,
intra-uterine device, diaphragm with spermicide, condom with spermicide, or
abstinence) for the duration of the study.

- Male subjects must agree to use an acceptable method for contraception for the
duration of the study.

Exclusion Criteria:

- Has active peripheral neuropathy of Grade 2 or greater intensity, as defined by the
National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE;
Version 3).

- Has experienced myocardial infarction within 6 months prior to enrollment or have New
York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina,
severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
acute ischemia or active conduction system abnormalities. Prior to study entry, any
ECG abnormality noted should be documented by the investigator as not medically

- Has been treated previously with VELCADE or ELOXATIN.

- Has had prior radiation therapy to the target lesion, unless the lesion is clearly
progressing and the interval between the most recent radiation therapy and enrollment
is at least 4 weeks.

- Has uncontrolled active systemic infection requiring therapy.

- Has a history of allergic reaction attributable to compounds containing boron or
mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.

- Female subject is pregnant or breast-feeding.

- Has had a serious concomitant systemic disorders (including oncologic emergencies)
incompatible with the study (at the discretion of the investigator).

- Has had a "currently active" second malignancy other than non-melanoma skin cancer or
carcinoma in situ of the cervix are not to be registered. Patients who are not
considered to have a "currently active" malignancy if they have completed therapy and
are considered by their physician to be at less than 30% risk of relapse.

- Has had any investigational agent within 4 weeks prior to enrollment into this study.

- Is unwilling to employ adequate means of contraception (condoms, diaphragm, birth
control pills, injections, intrauterine device, or abstinence).

- Has disease which cannot be radiologically imaged.

- Has a serious medical or psychiatric illness likely to interfere with participation
in this clinical study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate

Outcome Time Frame:

Every 28 days post cycle treatment

Safety Issue:


Principal Investigator

Robert N Taub, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Mesothelioma
  • Pleural Mesothelioma
  • Peritoneal Mesothelioma
  • Mesothelioma



Columbia University Medical Center New York, New York  10032