Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * To assess the anti-tumor activity, in terms of the percentage of patients who are treated with these regimens and who are progression-free at 6 months. * To assess the safety profile of each treatment regimen. Secondary * To estimate the response rate in patients treated with these regimens. * To estimate the distribution of progression-free survival time and overall survival time of patients treated with these regimens. Tertiary * To examine the impact of therapy on angiogenesis and immune homeostasis. OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1) and location of metastatic disease (M1a \[skin or subcutaneous tissue or lymph node only\] vs M1b \[lung\] vs M1c \[other visceral sites\]) and randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual 8/21/09) * Arm II: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for VEGF plasma levels and analysis of changes in immune homeostasis. Beginning at study entry, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
