Trial Information

Summary: Oxaliplatin (ELOXATINŽ) Plus Gemcitabine as First or Second-line Chemotherapy for Patients with Malignant Pleural or Peritoneal Mesothelioma. A Phase II Clinical Trial

The primary goal of this study is to determine the objective tumor response rate for Oxaliplatin plus gemcitabine in patients with malignant pleural mesothelioma and/or malignant peritoneal mesothelioma who have no more than one prior chemotherapy regimen and to record median survival for treated patients. Your participation in this study is completely voluntary. If you choose to withdraw from the study at any time you will be given the opportunity to discuss other treatment options with the study doctor.

Patient Inclusion Criteria

1. Ability to sign informed consent.
2. At least 18 years of age.
3. Histologically confirmed malignant pleural or peritoneal mesothelioma not amenable to curative treatment with surgery.
4. Disease status must be that of measurable disease as defined by modified SWOG criteria.
5. If pleurodesis was performed, there must be at least a 2-week delay before the start of treatment.
6. Adequate organ function and satisfactory laboratory results as determined by the treating physician.
7. Patients with reproductive potential must be willing to use an approved method of contraception for the duration of the study and at least 3 months after study completion.

Patient Exclusion Criteria

1. More than one previous regimen of systemic chemotherapy.
2. 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.
3. Active infection (at the discretion of the investigator).
4. Pregnancy or breast feeding.
5. Serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
6. Patients with a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
7. Use of any investigational agent within 4 weeks before enrollment into the study.
8. Disease which cannot be radiologically imaged.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.