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Oxaliplatin (Eloxatin®) Plus Gemcitabine as First or Second-line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Oxaliplatin (Eloxatin®) Plus Gemcitabine as First or Second-line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

Oxaliplatin (ELOXATIN®) is an organoplatinum complex which exerts its cytotoxic effect
chiefly through inhibition of tumoral DNA synthesis and repair, leading to cellular
apoptosis. The antiproliferative activity of oxaliplatin has been shown to approximate that
of cisplatin or carboplatin in different tumor types.

This is a phase II clinical trial of Oxaliplatin (ELOXATIN®) plus gemcitabine as first or
secondline chemotherapy for patients with malignant pleural or peritoneal mesothelioma. This
study aims to determine the objective tumor response rate for Oxaliplatin plus gemcitabine
given every 14 days in patients with malignant pleural mesothelioma and/or malignant
peritoneal mesothelioma who have no more than one prior chemotherapy regimen. A total of 29
patients are expected to be enrolled in the study, each with a participation duration of 6

Patients will be screened using standard health care assessments and tests. All of these
tests must be done within 4 weeks before patients begin treatment. Patients who are deemed
eligible will start the treatment cycle, defined as an interval of 14 days, and comprising
of treatment with Gemcitabine followed immediately by Oxaliplatin. The study drugs will be
administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90
minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.

In the absence of specific indications for discontinuation of study drugs, patients will
routinely be offered 6 cycles of therapy. Further cycles may be given if in the opinion of
the investigator this is in the patient's best interest.

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 IMTG TNM staging criteria (see Protocol Attachment 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.

- 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 (see Section

- 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

- CT (specifically spiral CT) scans and MRT 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 performed, there must be
at least a 2-week delay before Oxaliplatin or gemcitabine is administered. If the
original CT scan occurred prior to the pleurodesis, an additional CT scan is required
2 weeks or longer after the pleurodesis, which will then be considered the baseline

NOTE: For patients with clinically significant pleural effusions or ascites,
consideration should be given to draining the fluid.

- Performance status of 0, 1 or 2 on ECOG Performance Status Scale (after any
palliative measures including pleural drainage have occurred). See Protocol
Attachment 2.

- Estimated life expectancy of at least 12 weeks.

Exclusion Criteria:

- More than one previous regimen of systemic chemotherapy. Prior intracavitary
cytotoxic drugs will count as a prior regimen, unless given for the purpose of
pleurodesis. Immunomodulators will not be regarded as chemotherapy. Prior systemic
treatment with pemetrexed plus a platinum compound will not be a contraindication for

- 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.

- Active infection (at the discretion of the investigator).

- Pregnancy or breast feeding.

- Serious concomitant systemic disorders (including oncologic emergencies) incompatible
with the study (at the discretion of the investigator).

- Patients with 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.

- Use of any investigational agent within 4 weeks before enrollment into the study.

- Disease which cannot be radiologically imaged.

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:

Best Response

Outcome Description:

Radiologic response by RECIST criteria

Outcome Time Frame:

Two months

Safety Issue:


Principal Investigator

Robert N Taub, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:

AAAA2861 (Final)



Start Date:

April 2004

Completion Date:

March 2013

Related Keywords:

  • Mesothelioma
  • Mesothelioma
  • Mesothelioma



Columbia University Medical CenterNew York, New York  10032