A phase II trial of cisplatin, pemetrexed and bevacizumab in untreated malignant mesothelioma
Summary: A phase II trial of cisplatin, pemetrexed and bevacizumab in untreated malignant mesothelioma
The primary objective of this phase II trial in mesothelioma is to evaluate the activity of the experimental regimen of three therapeutic drugs used in combination, and to determine whether this experimental regimen has sufficient activity to merit further investigation. The primary endpoint will be progression free survival. Your participation in this study will be completely voluntary. If you chose to withdraw your participation at any time during the trial you can discuss other treatment options with the study doctor.
Patient Inclusion Criteria
1. Ability to understand and the willingness to sign a written informed consent document.
2. Patients must be > 18 years old
3. Patients must have histologically proven malignant mesothelioma not amenable to curative surgery or radiotherapy.
4. No prior treatment with an investigational agent or prior chemotherapy for this malignancy
5. Patients must have measurable disease.
6. 4 weeks since completion of prior radiation.
7. Patients must have acceptable laboratory results.
8. Patients with history of hypertension must be well-controlled (< 150/100) on a stable regimen of anti-hypertensive therapy.
9. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and through the duration of study participation.
10. Patients must agree to comply with vitamin B12 and folic acid supplementation.
Patient Exclusion Criteria
1. Patients must not be pregnant or breast feeding.
2. No "currently active" second malignancy other than non-melanoma skin cancer.
3. No uncontrolled intercurrent illness including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements.
4. No HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with study medications.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study.
6. Inability to interrupt aspirin or other non-steroidal medication for a 5 day period.
Elethea Hare, MSPA, RPA-C
161 Fort Washington Ave.
New York, NY 10032