Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI
الكلمات الدالة
نبذة مختصرة
وصف
There are two common combinations of chemotherapy drugs used to treat cancer of the colon, rectum, or appendix that has spread to the abdomen. One uses 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is called FOLFOX. The other uses 5-FU, leucovorin, and irinotecan, and is called FOLFIRI. The Food and Drug Administration (FDA) has approved each of these combinations as treatment for colon or rectal cancer. Each is given through the veins.
FOLFOX and FOLFIRI do not work well for tumors growing in the abdominal cavity. The investigators are trying to determine if giving chemotherapy called oxaliplatin directly into the abdominal cavity will have a greater effect on the cancer.
The FDA has approved oxaliplatin to be given to people through their veins to treat advanced colorectal cancer. Giving oxaliplatin directly into the abdomen in this study is experimental and is not approved by the FDA. This study will give the standard chemotherapy FOLFIRI through the veins and oxaliplatin directly into the abdomen. This is the first time intraperitoneal oxaliplatin is being given in combination with FOLFIRI.
تواريخ
| آخر التحقق: | 06/30/2020 |
| تم الإرسال لأول مرة: | 07/11/2016 |
| تم إرسال التسجيل المقدر: | 07/12/2016 |
| أول نشر: | 07/13/2016 |
| تم إرسال آخر تحديث: | 07/12/2020 |
| آخر تحديث تم نشره: | 07/14/2020 |
| تاريخ بدء الدراسة الفعلي: | 06/30/2016 |
| تاريخ الإنجاز الأساسي المقدر: | 07/31/2020 |
| التاريخ المتوقع لانتهاء الدراسة: | 08/31/2020 |
حالة أو مرض
التدخل / العلاج
Drug: Dose Escalation
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Experimental: Dose Escalation Single arm dose finding for intraperitoneal Oxaliplatin. All patients will receive experimental treatment.
The first cohort of 3 patients will receive dose level 1. The second cohort of 3 patients will receive dose level 2. The Third cohort of 3 patients with receive dose level 3. | Drug: Dose Escalation Intraperitoneal oxaliplatin will be given along with standard chemotherapy FOLFIRI.
Level 1: Oxaliplatin 25mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 2: Oxaliplatin 55mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 3: Oxaliplatin 85mg/m2 IP every 2 weeks on day #1 of chemotherapy |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | Inclusion Criteria: - Must be 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy - Must consent to participate in the trial and have signed an approved informed consent form conforming to institutional policy - Must have histopathologically or cytologically confirmed colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous peritoneal dissemination of disease.(Stage IV peritoneal based disease only) - Must have active measurable disease by either abdominal computerized axial tomography (CT)/ Magnetic resonance imaging (MRI) or laparoscopy. Adequate laboratory values - Absolute neutrophil count (ANC) > 1200/10*3/uL - Platelet count > 140,000/10*3/uL - Total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin >1.5 mg/dL are eligible only with Gilbert's syndrome) - Alkaline phosphatase < 2.5 times the upper limit of normal (ULN) (alkaline phosphatase and AST cannot both exceed the ULN) - Aspartate aminotransferase (AST) < 1.5 times the ULN (alkaline phosphatase and AST cannot both exceed the ULN) - Serum renal function parameters (BUN and creatinine) are within normal limits (eGFR) >50) - Satisfactory cardiopulmonary function (as determined by Physician) - Patients can have received prior systemic chemotherapy, radiation or surgery - Patients must be able to undergo placement of an intraperitoneal (IP) catheter and a Port-A Cath, if not already present - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less - Women of reproductive age and men who are sexually active must be willing to practice effective contraception - Patients will be allowed to have secondary malignancies as long as they do not require active concomitant treatment |
النتيجة
مقاييس النتائج الأولية
1. Define the maximum tolerated dose (MTD) of intraperitoneal (IP) oxaliplatin given with systemic FOLFIRI in patients with peritoneal carcinomatosis (PC) of colorectal or appendiceal origin [8 weeks]
