Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Folic Acid

Folinic Acid

Folate

Vitamin B9

FOLFOX A arm (14-day cycle)

* nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first).
* Oxaliplatin: 85mg/m2, IV over 2 hours, day 1.
* Folinic acid: 350mg flat dose, IV over 2 hours, day 1.
* Fluorouracil infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours or 48 hours as per local practice.)

Patients will also receive daily G-CSF as primary prophylaxis against neutropenic events for all cycles. This should be given as per local policy for chemotherapy regimens given every 14 days e.g. it may be started on day 4 for 7 days (preparation and dose should be given as per local policy).

Nab-Paclitaxel + Gemcitabine (AG) arm (28-day cycle)

* nab-paclitaxel: 125mg/m2 IV over 30 minutes on days 1, 8 and 15 (administered first).
* Gemcitabine 1000mg/m2 IV over 30 minutes on days 1, 8 and 15 (immediately following nab-paclitaxel).

* nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first).
* Oxaliplatin: 85mg/m2, IV over 2 hours, day 1.
* Folinic acid: 350mg flat dose, IV over 2 hours, day 1.
* Fluorouracil infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours or 48 hours as per local practice.)

FOLFOX-A

* nab-paclitaxel: 125mg/m2 IV over 30 minutes on days 1, 8 and 15 (administered first).
* Gemcitabine 1000mg/m2 IV over 30 minutes on days 1, 8 and 15 (immediately following nab-paclitaxel).

Derek Grose

PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery

This is an integrated, open label, non-randomised, phase II trial of 2 neo-adjuvant regimens (FOLFOX-A and AG) assessing efficacy and toxicity with integrated translational work. The study is powered on testing a proposed DNA damage response deficient biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG are recruited concurrently. The study has a prospective safety assessment of neo-adjuvant chemotherapy and neo-adjuvant chemotherapy followed by chemoradiotherapy consisting of conventional radiotherapy with concomitant capecitabine. This safety assessment will include all patients (FOLFOX-A and AG)

Patients are registered to receive either FOLFOX-A or AG depending on their age and performance status

PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer

PRIMUS002: An Umbrella Phase II Study Examining Two Neo-adjuvant Regimens (FOLFOX-A and AG) in Resectable and Borderline Resectable Pancreatic Ductal AdenoCarcinoma (PDAC), Focusing on Biomarker and Liquid Biopsy Development

Clinical data will be made available on request once clinical study report has been written and primary publication accepted by peer reviewed journal

date of progression after FOLFOX-A neo-adjuvant chemotherapy as assessed by RECIST 1.1

a liquid biopsy will be taken and analysed using circulating tumour DNA at different timepoints to see if these can be used to define patient subgroups

CT scans will be reported to RECIST 1.1 and best response will be evaluated

CAP tumour regression grade (grade 0-3 with 0 being no viable residual tumour and 3 being poor to no response) will be assessed post surgery

Overall survival will be assessed in all patients

Disease free survival will be assessed at every follow up visit

Safety and tolerability will be assessed as per NCI CTCAE 4.03

Safety and tolerability of chemoradiotherapy will be assessed as per NCI CTCAE 4.03

Rate of surgical complication as assessed by NCI CTCAE 4.03

Assessed by GOG NTX4 (4 questions graded from 0 (not at all) to 4 (very much). quality of life will be assessed using the GOG NTX4 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months)

quality of life will be assessed using the EORTC QLQ C30 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months). The Quality of life tool is comprised of 28 questions that the patient answers either 1-4 (1 = not at all, 4 = Very much) and 2 questions that are on al scale of 1 - 7 where 1 = very poor and 7 = excellent

quality of life will be assessed using the EORTC QLQ-PAN26 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months). The Quality of life tool is comprised of 26 questions that the patient answers either 1-4 (1 = not at all, 4 = Very much)

Health economics defined as number of visits to hospital per patient, both as an inpatient and as an outpatient will be assessed at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months)

NHS Greater Glasgow and Clyde

University of Glasgow

Judith Dixon-Hughes

Project Manager

Symptoms and General Pathology

Neoplasm Metastasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Nimotuzumab

Liver Extracts

Antineoplastic Agents, Immunological

Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy.

Nimotuzumab 400 mg will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery.

Patients will receive AG as conversion therapy up to 6 months. Gemcitabine 1000 mg/m\^2 will be administered on Day 1, 8, 15 of a 28-day cycle. nab-Paclitaxel 125 mg/m\^2 will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery.

Huikai Li, Dr

Jihui Hao, Dr

This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (gemcitabine and nab-paclitaxel) in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis

A Prospective, Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis

The Proportion of patients who achieved R0 resection (incisal edge\>1cm)

The proportion of patients who underwent surgery.

The time from the beginning of treatment to death due to any cause.

Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.

To explore the influence of tumor-related markers (such as CA199,EGFR) on prognosis.

Frequency and severity of adverse events.

Tianjin Medical University Cancer Institute and Hospital

Vitamin B Complex

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

nab-paclitaxel at 100 mg/m\^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15

oxaliplatin at 85mg/m\^2 on days 8 and 22, folinic acid at 200mg/m\^2 on days 1,8,15 and 22, fluorouracil at 2000mg/m\^2 on days 1,8,15 and 22.

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.

nab-paclitaxel

Patients secondly receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.

gemcitabine

Patients receive oxaliplatin 85 mg/m\^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Treatment repeats until there is disease progression or recurrence. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days.

oxaliplatin

Patients receive folinic acid 200 mg/m\^2 (iv) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.

folinic acid

Patients receive fluorouracil 2000 mg/m\^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.

fluorouracil

Xian-Jun Yu, M.D PH.D

Wen-Quan Wang, M.D PH.D

Sheng-Ping Li, M.D PH.D

Cheng-Hao Shao, M.D PH.D

Xian-Jun Yu, M.D., Ph.D.

Wen-Quan Wang, M.D., Ph.D.

Xianjun Yu, M.D., Ph.D.

Wei Wang, M.D PH.D

De-Liang Fu, M.D PH.D

Ji-Hui Hao, M.D PH.D

Yi-Ping Mou, M.D PH.D

The purpose of this study is to investigate the activity and safety of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.

PRIMARY OBJECTIVES:

* To evaluate the therapeutic efficacy of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection.

SECONDARY OBJECTIVES:

* To evaluate the therapeutic efficacy of two regimens in terms of objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* To evaluate the time to remission of patients treated with the two regimens.
* To evaluate the progression-free survival of patients treated with the two regimens.
* To evaluate the levels of tumor biomarkers in serum of patients treated with the two regimens, including Carbohydrate Antigen (CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP.
* To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 4.0 in patients treated with the two regimens.
* To evaluate the quality of life score of patients treated with the two regimens.

Detailed Description of Arms:

Patients are randomized to 1 of 2 treatment arms (Arm AG or Arm OFF). Arm AG: Firstly, patients receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Secondly, patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.

Arm OFF: Patients receive oxaliplatin 85 mg/m\^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Patients receive folinic acid 200 mg/m\^2 (iv) and fluorouracil 2000 mg/m\^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days. Treatment repeats until there is disease progression or recurrence.

Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

A Prospective, Multi-centric, Phase Ⅲ, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine (AG) Versus Oxaliplatin Plus Folinic Acid and Fluorouracil (OFF) for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

To evaluate the therapeutic efficacy of second-line adjuvant therapy with AG versus OFF in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection. Outpatient visit, phone interview

To evaluate the therapeutic efficacy of two regimens in terms of objective response rate. Computed tomography (CT) scan

To evaluate the time to remission of patients treated with the two regimens. Computed tomography (CT) scan

To evaluate the progression-free survival of patients treated with the two regimens. Computed tomography (CT) scan

To evaluate the levels of tumor biomarkers in serum of patients treated with the two regimens, including Carbohydrate Antigen (CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP . Outpatient visit, laboratory findings

To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0) in patients treated with the two regimens. The toxicity profile includes but not limits neutropenia, thrombocytopenia, peripheral neuropathy, hypoglycemia, metabolic acidosis (acute or chronic, including ketoacidosis), which will be summarized as the percentage of patients by type and grade according to treatment group. Outpatient visit, laboratory findings.

To evaluate the quality of life score of patients treated with the two regimens. Outpatient visit, phone interview

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer	NCT04176952	Neoplasms Pancr...	FOLFOX-A AG	16 Years -	University of Glasgow
Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis	NCT06405685	Pancreatic Canc...	Nimotuzumab AG	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection	NCT02506842	Stage ⅠA Pancre... Stage ⅠB Pancre... Stage ⅡA Pancre... Stage ⅡB Pancre...	nab-paclitaxel gemcitabine oxaliplatin folinic acid fluorouracil	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for ag

Every month we try and update this database with for ag 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 ag

Every month we try and update this database with for ag 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 ag 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.