Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Digestive System Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Ascorbic Acid

Gemcitabine

Trace Elements

Antioxidants

Protective Agents

Erlotinib Hydrochloride

Vitamin C

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Daniel A Monti, MD

Edith P Mitchell, MD

The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data

Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. If vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.

Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca

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

Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.

1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.

Thomas Jefferson University

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

Ascorbic Acid, Gemcitabine & Erlotinib

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Daniel Monti

The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.

Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer

Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument

Overall Study

Symptoms and General Pathology

Recurrence

Carcinoma

Adenocarcinoma

Carcinoma, Hepatocellular

Liver Diseases

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Angiogenesis Inhibitors

Sorafenib

Enzyme Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity

ABT-869

Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.

Justin Ricker, MD

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

Abbott

Colorectal Neoplasms

Colonic Diseases

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Irinotecan

Camptothecin

Topoisomerase I Inhibitors

Cola

Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks

350mg/m2 irinotecan once a week every 3 weeks

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.

Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer

The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.

Ascorbic Acid (50-100g, 3x weekly)

Ascorbic Acid: 3x a week for 9 weeks

Ascorbic Acid+Irinotecan

Standard of Care (Irinotecan Alone)

Total

The Phase 2 portion of this study never enrolled and therefore no patients were enrolled to the standard of care arm.

The study was closed early due to lack of accrual. The data were not collected or analyzed.

Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Number of Participants That Are Alive After 11 Weeks.

Adenoma

Neuroendocrine Tumors

Neoplasms, Germ Cell and Embryonal

Adenoma, Islet Cell

Neoplasms, Nerve Tissue

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neuroendocrine Tumor

Neuroepithelioma

Sunitinib

sunitinib 37.5 mg/day (per os) for 6 months

Sutent

Eric Raymond, Professor

The purpose of this study is to identify predictive molecular markers of response to continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.

Hypothesis:

* To distinguish molecular markers based on their expression at the initial biopsy, their detection by proteomic analysis and demonstrating that tumor or vascular cells are straightaway sensitive to sunitinib (markers sensitivity).
* The presence of these markers at the initial biopsy predict the sensitivity to sunitinib(Positive predictive value of markers)

Neuroendocrine tumors (NET) are rare malignancies (1-2% of digestive cancers); and there is, in recent years, a slow but steady increase in their incidence. Despite the joint efforts of several research groups, which led to the new WHO classification (2002), the natural history of the disease remains heterogene and the resistance to conventional cytotoxic treatment remains the common denominator of these tumors.

Indeed, the prognosis of patients with metastatic disease remains poor despite numerous treatments (including: IFN, DTIC, 5-FU, doxorubicin, somatostatin analogues, etc.).

None of which showed a benefit in terms of survival. The main therapeutic objective is still to get a palliative effect on the symptoms and / or limit a few months tumor progression.

There are many publications showing that angiogenesis is one of the major mechanisms of tumor progression in TNE. But the multiple signaling pathways involved, the existence of alternative routes and their relationship to apoptosis inducing molecules remain unknown. Sunitinib is a new molecule in the family of tyrosine kinase inhibitors targeting multiple receptors which VEGFR, KIT, PDGF-R, FLT3 and RET. Since 2006 year, Sunitinib has been approved to treat advanced kidney cancer also called advanced renal cell carcinoma (a typically chemoresistant disease for which there was no active treatment available).

Many retrospective studies in patients showing that the TNE overexpress one or more targets of sunitinib. In Phase I trial, an antitumor activity has been identified in neuroendocrine tumors. In a phase II trial including 100 patients with well-differentiated TNE and carcinoids, sunitinib is associated with a response rate of 10%, and 82% of clinical benefit in the form of tumor stability.

Currently, an international randomised phase III trial initiated in well differentiated forms, but no studies are underway for poorly-differentiated TNE.

All of this suggests that sunitinib could represent an important therapeutic option for moderate, or poorly differentiated inoperable TNE and needs to be explored in this pathology by identifying predictive biomarkers of response.

Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors

A Multicenter Phase II Open Study Coupled With a Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.

to assess the correlation between the expression of biomarkers and CT scan response. Patients are considered as responders when objective response (Partial or complete response) is showed on CT scan.

* Objective response according to RECIST criteria (Time Frame: duration of study Safety issue: No).
* Overall Survival (Time Frame: 6 months. Safety issue: No).
* Progression-free survival (PFS)
* Correlation between overall survival, PFS and tumor necrosis assessed on CT scan

correlation between the concentration of sunitinib and its major active metabolite, SU012662, and objective response and /or toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca	NCT01555489	Stage IV Pancre...	Ascorbic Acid	18 Years -	Thomas Jefferson University
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)	NCT01009593	Hepatocellular ... Hepatocellular ... Carcinoma, Hepa... Liver Diseases Neoplasms by Hi... Digestive Syste... Carcinoma Liver Neoplasms Neoplasms Neoplasms by Si... Digestive Syste... Adenocarcinoma Neoplasms, Glan...	ABT-869 Sorafenib	18 Years -	Abbott
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca	NCT01555489	Stage IV Pancre...	Ascorbic Acid	18 Years -	Thomas Jefferson University
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)	NCT01009593	Hepatocellular ... Hepatocellular ... Carcinoma, Hepa... Liver Diseases Neoplasms by Hi... Digestive Syste... Carcinoma Liver Neoplasms Neoplasms Neoplasms by Si... Digestive Syste... Adenocarcinoma Neoplasms, Glan...	ABT-869 Sorafenib	18 Years -	Abbott
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University
Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors	NCT01215578	Neuroendocrine ... Pancreatic Neop... Advanced Diseas... Sunitinib	Sutent	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for growth substances