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New treatment option for Metastatic Small Intestinal Adenocarcinoma
Official title Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
ClinicalTrials.gov ID: NCT04205968
What this study is testing
What is Fluorouracil?
Fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic small intestinal adenocarcinoma.
Also referred to as 5 Fluorouracil, 5 Fluorouracilum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed small bowel adenocarcinoma. Ampullary adenocarcinomas are not eligible. Patients must...
- 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 have measurable or non-measurable disease. All scans needed for assessment of measurable disease must be performed within 28 days prior...
- Patients must have progressed on prior therapy with a fluoropyrimidine and/or oxaliplatin, given either for metastatic/locally advanced disease or as...
- Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be...
You likely can't join if
- Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma
- 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...
- Patients must not be currently enrolled in or have discontinued within the last 28 days a clinical trial involving an investigational product or...
- Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents
- Patient must not have a known bleeding diathesis
- Patient must not have uncontrolled or poorly-controlled hypertension (\> 160 mmHg systolic or \> 100 mg HG diastolic for \> 4 weeks) despite standard...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 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...
- 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
- Absolute neutrophil count (ANC) \>= 1,500/mcL (must be obtained within 28 days prior to registration)
- Platelets \>= 100,000/mcL (must be obtained within 28 days prior to registration)
- A total bilirubin =\< 1.5 x institutional limit normal (IULN) (must be obtained within 28 days prior to registration)
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =\< 3.0 x IULN (or 5.0 x IULN if liver metastases are...
- Serum creatinine =\ = 40 mL/min (must have been obtained within 28 days prior to registration)
- Patient must have urinary protein =\ = 2+, a 24 - hour urine collections for protein must demonstrate \< 1000 mg of protein in 24 hours
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients must not have known dihydropyrimidine dehydrogenase deficiency
- Patients must be offered the opportunity to participate in specimen banking
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
What rules you out
- Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma
- 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...
- 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...
- Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents
- Patient must not have a known bleeding diathesis
- Patient must not have uncontrolled or poorly-controlled hypertension (\> 160 mmHg systolic or \> 100 mg HG diastolic for \> 4 weeks) despite standard medical management
- Patient tumors must not have known deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H)
- Patients must not be pregnant or nursing and must have had a negative pregnancy test within 4 weeks of starting treatment. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A...
- Patients must not have an active infection requiring systemic therapy
- Patient must not have liver dysfunctions manifested by either (1) Child-Pugh B (or worse) or (2) cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis...
- Patients must not have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered...
- Patients must not have experienced any arterial thrombotic event (including but not limited to myocardial infarction, unstable angina, stable angina markedly limiting ordinary physical activity, cerebrovascular...
- Patients must not have a prior history of gastrointestinal (GI) perforation/fistula or other risk factors for perforation within 120 days prior to registration
- Patients must not have experienced any grade 3-4 GI bleeding within 90 days prior to registration
- Patient must not have experienced any serious or non-healing wound, ulcer, or bone fracture within 28 days prior to registration
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Fontana, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Napa, California, United States
- Ontario, California, United States
+ 340 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Hot Springs, Arkansas, United States; Jonesboro, Arkansas, United States and 354 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.