Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Yi-Ming Shyr, M.D.

Tsann-Long Hwang, M.D.

Ruey-Kuen Hsieh, M.D.

Study Design:

Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent.

The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.

We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.

The specimen and clinical information will be collected and delivered to the laboratory of Dr. Hui-Ju Ch'ang over NICR, NHRI, Tainan .

Biomarkers Study in Pancreatic Cancer

National Taiwan University Hospital

Chang Gung Memorial Hospital

Taipei Veterans General Hospital, Taiwan

Mackay Memorial Hospital

Taichung Veterans General Hospital

National Cheng-Kung University Hospital

Kaohsiung Veterans General Hospital.

Kaohsiung Medical University

National Health Research Institutes, Taiwan

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Osteosarcoma

Sarcoma

Neoplasm Metastasis

Neoplastic Processes

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Bone Density Conservation Agents

Micronutrients

Hematinics

Vitamins

Cyclophosphamide

Methotrexate

Sirolimus

Zoledronic Acid

Temsirolimus

MTOR Inhibitors

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Folinic Acid

Folate

Vitamin B9

Drug : Metronomic Cyclophosphamide, Methotrexate, Sirolimus, Zoledronic acid Assessment of the maximum tolerated dose of sirolimus Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV).

Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV).

Trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the MTD is established.

Sirolimus combined with CP, MT and ZA

Maud TOULMONDE, Doctor

This is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the Maximum Tolerated Dose (MTD) is established.

The dose escalation part of the trial will be concerned on adults with advanced solid tumor with bone metastasis and young and adult patients with unresectable locally advanced or metastatic osteosarcoma.

The Expansion cohort will be conducted on young and adult patients with unresectable locally advanced or metastatic osteosarcoma.

Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma

Metronomic Cyclophosphamide and Methotrexate Combined With Zoledronic Acid and Sirolimus in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma. A Phase Ib Study From the French Sarcoma Group

Reliable Cancer Therapies

Pfizer

Institut Bergonié

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarkers Study in Pancreatic Cancer	NCT01666184	Biomarkers Stud...		20 Years - 75 Years	National Health Research Institutes, Taiwan
Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma	NCT02517918	Solid Tumor Osteosarcoma	Sirolimus combi...	13 Years -	Institut Bergonié
Biomarkers Study in Pancreatic Cancer	NCT01666184	Biomarkers Stud...		20 Years - 75 Years	National Health Research Institutes, Taiwan

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