Clinical Trial Information
Protocol: SWOG – S1922
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss eligibility requirements.
- Patients must have histologically or cytologically confirmed small bowel adenocarcinoma. Ampullary adenocarcinomas are not eligible. Patients must have metastatic disease or locally advanced unresectable disease.
- Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to registration. Patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration.
- Patients must have measurable or non-measurable disease. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration.
- Patients must have progressed on prior therapy with a fluoropyrimidine and/or oxaliplatin, given either for metastatic / locally advanced disease or as adjuvant therapy completed within the previous 12 months.
- Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma.
- Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be resolved to Grade 1 (with the exception of Grade 2 neuropathy) prior to registration. In CTCAE version 5.0 Grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs)”
- Patients must not have had major surgery within 28 days prior to registration, or minor surgery within 7 days prior to registration, and must not be planned for elective major surgery to be performed during protocol treatment.
- Patients must not be currently enrolled in or have discontinued within the last 28 days a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients participating in surveys or observational studies are eligible to participate in this study.
- Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents.
- Patients must be ≥ 18 years of age.
- Patients must have a complete medical history and physical exam within 28 days prior to registration.
- Patients must have a Zubrod Performance Status of 0 or 1.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patient tumors must not have known deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H).