Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced… (NCT03694002) | Clinical Trial Compass
CompletedPhase 2
Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery
United States21 participantsStarted 2019-03-20
Plain-language summary
This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without ramucirumab will work better in treating patients with thymic cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed thymic carcinoma; thymic carcinoma may be defined as "thymic epithelial malignancy, consistent with thymic carcinoma", or "World Health Organization (WHO) type C thymic epithelial tumor", or "thymic epithelial malignancy" with radiographic imaging consistent with thymic carcinoma
* Patients must have unresectable thymic carcinoma, that is either locally advanced, recurrent, or metastatic
* Patients must not be candidates for localized surgery
* Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 calendar days prior to randomization; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 calendar days prior to randomization; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
* Patients must have a Zubrod performance status of 0 to 2
* Patients must not have undergone major surgery within 28 calendar days prior to randomization, or minor surgery/subcutaneous venous access device placement within 7 calendar days prior to randomization; the patient must not have elective or planned major surgery to be performed during the course of the clinical trial
* Patients must not have had prior systemic anti-cancer therapy for l…