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

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Bevacizumab

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

bevacizumab

1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.

gemcitabine

oxaliplatin

Mehrdad Jafari, MD, PhD

The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival.

In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin, and gemcitabine together.

Design:

* A phase II single arm study. All patients receive bevacizumab 10mg/kg and gemcitabine 1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 on day 2 of a 14 day cycle.

Purpose:

* The purpose of this study is to find out if giving patients bevacizumab, along with the chemotherapy drugs oxaliplatin and gemcitabine, will improve overall survival. In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin and gemcitabine together.

Enrollment:

* Approximately 30 patients will be enrolled to the study between the University of Oklahoma and M.D. Anderson Cancer Center.

Duration:

* The study will be conducted over approximately 2 years.

Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer

Genentech, Inc.

Sanofi

M.D. Anderson Cancer Center

University of Oklahoma

Mehrdad Jafari, MD

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Vinorelbine

Docetaxel

Tubulin Modulators

Antimitotic Agents

Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles

Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles

Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Vassilis Georgoulias, MD

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial

University Hospital of Crete

Hellenic Oncology Research Group

V.Georgoulias

Adenocarcinoma

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Micronutrients

Hematinics

Vitamins

Amino Acids

Pemetrexed

Cisplatin

Gefitinib

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)

Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)

Placebo

Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles

Pemetrexed plusCIsplatin

Jin Soo Lee, M.D. PhD.

SUNG JIN YOON, RN

Sung Jin Yoon, RN

Jin Soo Lee, MD. Ph.D.

Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Investigators believe this PFS curve crossing-over in both IPASS and First-SIGNAL study is mainly due to early progression of EGFR mutation-negative tumors after gefitinib alone. Taken together with the FASTACT trial results, this PFS curve crossing-over may well be averted if effective chemotherapy is given together with gefitinib in a most optimum timing and sequence. Apparently, timing of EGFR-TKI administration within chemotherapy cycles is very critical, as shown in OSI 9774 trial.

In this placebo-controlled randomized phase II, Investigators propose to give gefitinib on days 5-18 of a 3-weekly chemotherapy cycle of pemetrexed/cisplatin to avoid any potential overlap of EGFR-TKI effects on chemotherapy or vice versa. Investigators would like to generate promising pilot data, which warrants a large phase III trial. Investigators hope to show that intercalated administration of Iressa® (gefitinib) and Pemetrexed/platinum regimen improves the outcome of never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers

A Randomized Placebo-controlled Phase II Study of Intercalated Administration of Pemetrexed/Cisplatin With Iressa® (Gefitinib) or Placebo as First-line Treatment of Stage IIIB/IV Lung Adenocarcinoma in Never-smokers

from date of randomization until the date of first documented progression or death from any case.

Assessed minimum 1 years.

Participants will be followed for the duration of chemotherapy. CTCAE version 4.0

AstraZeneca

National Cancer Center, Korea

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hormones

Letrozole

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Novartis

The course of the disease in female patients with metastatic mammary carcinoma can vary greatly. In this connection, the individual prognosis depends on a complex interaction of tumor- and patient-related factors. To take account of such differences, it is necessary to employ individual methods of treatment which are suited to the course of each patient's disease. Prof. Possinger and Dr. Schmid (Charite Berlin) and Prof. Wischnewsky (University of Bremen) have developed an approach that can help to achieve this goal with the aid of computerized machine learning techniques (MLT).

The use of machine learning methods can be beneficial in oncology in two respects. On the one hand, an attempt can be made to individually estimate clinically relevant parameters like, for example, the recurrence probability or expected survival time as precisely as possible based on the established prognostic factors. And on the other hand, it may be possible with the aid of MLT to understand structural relationships between the clinical result and measured or established tumor-/patient-related variables.

To analyze the possible benefits of machine learning techniques for patients with metastatic breast cancer, the aim of study FEM-D-2 is to investigate whether it is possible to characterize those patients who either do or do not respond to a specific treatment with a precision of 90%, prospectively estimate the time until worsening of the disease under a given treatment, and classify patients in groups with favorable and poor chances of medium-term survival.

The use of inductive learning algorithms with machine learning also makes it possible to very accurately estimate the time until progression of the tumor growth. In patients who respond to letrozole therapy, the time until tumor progression depends on factors like pain, age, body mass index, disease-free interval, main localization of metastatic spread, and response to previous estrogen therapy. Only very minimal differences are found when comparing the actual time until progression of the disease and that calculated by the system (at least for survival times \< 1 year). Furthermore, using machine learning techniques it has become possible to use initial data assessed before a letrozole treatment to estimate the survival time and distinguish patients with a high risk of dying soon from other patients with a more favorable prognosis.

Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment

Novartis Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer	NCT00222469	Metastatic Panc...	bevacizumab gemcitabine oxaliplatin	18 Years -	University of Oklahoma
Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer	NCT00441740	Non Small Cell ...	Vinorelbine Gemcitabine Docetaxel Gemcitabine	18 Years - 75 Years	Hellenic Oncology Research Group
Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer	NCT00441740	Non Small Cell ...	Vinorelbine Gemcitabine Docetaxel Gemcitabine	18 Years - 75 Years	Hellenic Oncology Research Group
Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers	NCT01502202	Non Small Cell ... Adenocarcinoma	Gefitinib Placebo Pemetrexed plus...	18 Years -	National Cancer Center, Korea
Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer	NCT00441740	Non Small Cell ...	Vinorelbine Gemcitabine Docetaxel Gemcitabine	18 Years - 75 Years	Hellenic Oncology Research Group
Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment	NCT00241046	Metastatic Brea...	Letrozole	18 Years -	Novartis
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer	NCT00222469	Metastatic Panc...	bevacizumab gemcitabine oxaliplatin	18 Years -	University of Oklahoma
Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment	NCT00241046	Metastatic Brea...	Letrozole	18 Years -	Novartis

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