Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Irinotecan

Fluorouracil

Albumin-Bound Paclitaxel

mFOLFIRI irinotecan 130-150mg/m2 iv d1 LV 200 mg/m2 iv 2h d1 5-FU 400 mg/m2 IV d1 5-FU 2.4-3 g/m2 CI 46-h repeat every 2 weeks

mFOLFIRI

zhang xiaodong, MD

zhang xiaotian, MD

shen lin, MD

There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial

Peking University

zhang xiaodong

Peritoneal Neoplasms

Appendiceal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Abdominal Neoplasms

Peritoneal Diseases

Cecal Neoplasms

Cecal Diseases

Micronutrients

Oxaliplatin

Leucovorin

Tin Fluorides

Dose Level 0: 85 mg/m2 Oxaliplatin IP every 2 weeks

Dose Level 1: 95 mg/m2 Oxaliplatin IP every 2 weeks

Dose Level 2: 105 mg/m2 Oxaliplation IP every 2 weeks

Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue as described in the protocol until DLT stopping rules are met or the highest dose level is reached.

mFOLFIRI is a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan administered on day one of a 14-day cycle. 5-Fluorouracil, leucovorin, and irinotecan should be prepared and administered per the package insert and local institutional guidelines.

Laura Lambert, MD

This study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI.

This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established.

After consent and once deemed eligible for trial participation, patients will receive four cycles of study therapy. During therapy, patients will be monitored for dose-limiting toxicities and adverse events. After completion of all four cycles patients will be followed until resolution of any ongoing study treatment-related adverse events, initiation of alternative treatment, and survival.

Study drug treatment will be administered on day one of a 14-day cycle and the DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three). The severity of AEs will be graded according to the NCI-CTCAE version 5.0 A standard 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) while ensuring the safety and tolerability of the treatment. The study will test three dose levels of oxaliplatin.

Dose Level 2 105 mg/m2 IP every 2 weeks Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue until DLT stopping rules are met or the highest dose level is reached.

This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established.

Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer

Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous mFOLFIRI for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer

The incidence of DLTs during the defined DLT period

To assess the safety and feasibility of IP oxaliplatin when administered with systemic mFOLFIRI in patients with peritoneal carcinomatosis of colorectal or appendiceal origin.

• Objective response rate (ORR) after four cycles of study therapy. ORR will be assessed by the number of patients obtaining a complete response plus the number of patients obtaining a partial response divided by the number of total response evaluable subjects.

• Overall survival (OS) will be assessed as the time from trial initiation until death by any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial	NCT01044420	Advanced Esopha...	mFOLFIRI	18 Years - 70 Years	Peking University
Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer	NCT04158349	Colorectal Canc... Appendiceal Can... Peritoneal Carc...	Oxaliplatin mFOLFIRI	18 Years -	University of Utah
Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer	NCT04158349	Colorectal Canc... Appendiceal Can... Peritoneal Carc...	Oxaliplatin mFOLFIRI	18 Years -	University of Utah

Spots Global Cancer Trial Database for mfolfiri

Every month we try and update this database with for mfolfiri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mfolfiri

Every month we try and update this database with for mfolfiri cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mfolfiri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.