Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
PRIMARY OBJECTIVE: I. To compare progression‐free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin‐paclitaxel with or without ramucirumab. SECONDARY OBJECTIVES: I. To evaluate the frequency and severity of toxicity of carboplatin‐paclitaxel with or without ramucirumab in this patient population. II. To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms. III. To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms. IV. To compare overall survival between treatment arms. ADDITIONAL OBJECTIVE: I. To bank specimens for future research. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive ramucirumab intravenously (IV) over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year. ARM B: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 1 year.
Epistemonikos ID: 0327472768b3a7fe637ba1ee42cb9568886d1cd9
First added on: May 21, 2024