Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Erlotinib Hydrochloride

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy

Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)

Gemcitabine and Erlotinib

Joan Maurel, MD

This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.

Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma

Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events.

Safety population will include all subjects that have taken at least one study medication dose.

Grupo Espanol Multidisciplinario del Cancer Digestivo

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Micronutrients

Vitamins

Ascorbic Acid

Vitamin C

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Intravenous Vitamin C

Daniel Monti, MD, MBA

Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer	NCT01389440	Pancreatic Aden...	Gemcitabine and...	18 Years - 75 Years	Grupo Espanol Multidisciplinario del Cancer Digestivo
Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer	NCT01389440	Pancreatic Aden...	Gemcitabine and...	18 Years - 75 Years	Grupo Espanol Multidisciplinario del Cancer Digestivo
Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer	NCT00954525	Metastatic Panc...	Gemcitabine and... Intravenous Vit...	18 Years - 75 Years	Thomas Jefferson University

Spots Global Cancer Trial Database for gemcitabine and erlotinib