Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Neoplasm Metastasis

Colorectal Neoplasms

Neoplasms, Second Primary

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Liver Diseases

Hematinics

All Drugs and Chemicals

Micronutrients

Antineoplastic Agents

Vitamins

Liver Extracts

Leucovorin

Fluorouracil

Oxaliplatin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Adecatumumab,6-9mg/kg, every 14 days, 24 cycles

Adecatumumab

FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles

Adecatumumab and FOLFOX

FOLFOX 4

Peter Neuhaus, Prof. Dr.

Patrick Dufour, Pr. Dr.

The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.

Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

Amgen Research (Munich) GmbH

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Paclitaxel

Capecitabine

Levoleucovorin

Albumin-Bound Paclitaxel

Ramucirumab

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Folinic Acid

* RAMUCIRUMAB 8 mg/kg on Days 1 and 15 of every 28-day cycle
* PACLITAXEL 80 mg/m2 on Days 1, 8, and 15 of every 28-day cycle until progressive disease, unacceptable toxicity, informed consent withdrawal or patient's death.

* FOLFOX4: Oxaliplatin 85 mg/m2 + l-Leucovorin 100 mg/m2 + 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days.
* mFOLFOX6: Oxaliplatin a 85 mg/m2+ l-Leucovorin 200 mg/m2 + 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.
* XELOX:Oxaliplatin130 mg/m2 + Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

RAMUCIRUMAB

mFOLFOX 6

XELOX

MARIA DI BARTOLOMEO, MD

Filippo Pietrantonio, MD

SILVIA LAZZATI

MARIA DI BARTOLOMEO

This is a randomized, open-label, multicenter phase III trial of ramucirumab plus paclitaxel, given as switch maintenance, versus continuation of first-line chemotherapy, given as per standard clinical practice, in subjects with unresectable locally advanced or metastatic HER-2 negative gastric or GEJ cancer, without disease progression following 3 months of first-line doublet chemotherapy.

The acceptable first-line or lead-in chemotherapy will be:

* FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days.
* ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.
* XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

Treatment must be continued for up to 4 three-weekly cycles or 6 bi-weekly cycles, or for up to a maximum of 12 weeks. Subjects with CR/PR/SD after oxaliplatinum compound and fluoropyrimidine-based regimens, or without evidence of progressive disease in case of non-measurable disease, will be randomized in 1:1 ratio between the two treatment arms.

Prior to randomization, subjects will be stratified based on Center; Prior gastrectomy: No vs. Yes; Peritoneal carcinomatosis: Yes vs. No; Site of origin: GEJ vs. gastric.

Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers

Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers: the ARMANI Phase III Trial

Duration of response of patients who receive swich maintenance (arm A) versus patients who receive continuation therapy (arm B).

To compare the percentage of patients that will receive a second line therapy according to arm treatment.

Incidence of adverse events, according to CTCAE v4.03

PRO are assessed using the questionnaires EORTC QLQ-C30

PRO are assessed using the questionnaire the EORTC QLQ-OG25

PRO are assessed using the questionnaire EuroQol EQ-5D

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases	NCT00866944	Liver Metastase... Colorectal Canc...	Adecatumumab Adecatumumab an... FOLFOX 4	18 Years -	Amgen Research (Munich) GmbH
Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers	NCT02934464	Stomach Neoplas...	RAMUCIRUMAB Paclitaxel FOLFOX 4 mFOLFOX 6 XELOX	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases	NCT00866944	Liver Metastase... Colorectal Canc...	Adecatumumab Adecatumumab an... FOLFOX 4	18 Years -	Amgen Research (Munich) GmbH

Spots Global Cancer Trial Database for folfox 4

Every month we try and update this database with for folfox 4 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 folfox 4

Every month we try and update this database with for folfox 4 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 folfox 4 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.