Status:
COMPLETED
Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
Lead Sponsor:
Columbia University
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In patients with pleural or peritoneal mesothelioma, what is the response rate to combined Oxaliplatin (ELOXATIN®) and Gemcitabine chemotherapy?
Detailed Description
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 antiproliferat...
Eligibility Criteria
Inclusion
- 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 International Mesothelioma Interest Group staging criteria. 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 Southwest Oncology Group (SWOG) criteria.
- 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 computerized tomography (CT) scans. At least one level must have one rind measurement ≥15 mm.
- CT (specifically spiral CT) scans and magnetic resonance imaging (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 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 scan.
- 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 Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (after any palliative measures including pleural drainage have occurred).
- Estimated life expectancy of at least 12 weeks.
Exclusion
- 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 gemcitabine-oxaliplatin.
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00859469
Start Date
April 1 2004
End Date
March 1 2013
Last Update
October 30 2019
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032