Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Carcinoma

Prostatic Neoplasms

Disease Progression

Neoplasms, Hormone-Dependent

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Docetaxel

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

sunitinib

stephane OUDARD, professor

as second-line treatment in metastatic prostate cancer, the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6 cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be treated until disease progression, pain progression, unacceptable toxicity or death due to any cause.

Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

Follow-up for up to 1 year from the last dose of sunitinib.

* Antitumor efficacy of sunitinib will be assessed as follows:

  * PSA response rate and PSA progression according Working Group Criteria,
  * Variation of PSA doubling time (PSADT) before and after initiation of the treatment,
  * Objective response rate (ORR) according to RECIST criteria,
  * Clinical benefit,
  * Overall survival (OS).
* Pharmacokinetic endpoints will include sunitinib and its metabolite, SU012662, plasma levels and estimation of the population pharmacokinetic parameters as well as the inter-individual variability of these parameters, for a subgroup of 30 patients.
* The biological effects of sunitinib in patients with metastatic prostate carcinoma will be evaluated by measurements of the different biological markers that could be modulated by this antiangiogenic therapeutic, and could then predict and monitor disease progression and response to treatment:

  * Bone tumor markers: bone resorption markers (uCTX, uCTX, ICTP, CTX-MMP and TRACP-5b), bone formation markers (OC, PINP and BALP), osteoclastogenesis markers (OPG and RANKL) and parameters as calcium, phosphate, creatinine, albumin, PTH and 25(OH)D.
  * Angiogenesis markers: bFGF, SDF-1, VEGF-A, VEGFR1 and VEGFR2, CECs and CEPs, endothelial and platelet microparticles.

An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer

An Open Label Phase II Study of Oral Treatment With Sunitinib (SUTENT) in Patients Suffering From Hormone Refractory Prostate Cancer After Progression With Docetaxel Based Regimen

Assistance Publique - Hôpitaux de Paris

Endometrial Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

Tumor biopsy study

Britt Edvardsen, AVD ING

Ingjerd Bergo, Tech

Frederic Amant, MD, PhD

Tjugum Jostein, MD, PhD

Klaus Oddenes, MD

Marie E Engh, Prof

Annetine Staff, MD PhD

Solveig Tingulstad, Prof

Jan A. Rokne, MD

Margareth S. Lode, MD

Janusz Marcickiewicz, MD, PhD

Helga B. Salvesen, Prof., MD, PhD

The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.

Tumor specimens from endometrial carcinoma, from curettage and hysterectomy specimens, formalin-fixed and paraffin-embedded and fresh frozen, stored at minus 80 °C, corresponding blood samples with normal DNA

Molecular Markers in Treatment in Endometrial Cancer

Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.

Helse-Bergen HF

Norwegian Cancer Society

University of Bergen

Professor, MD, PhD

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Additional biopsies by means endoscopy, 5 from tumor tissue, 5 from adjacent normal mucosa per patient.

biopsies will be evaluated with immunohistochemistry and gene expression studies

biopsy

Jon Erik Grønbech, MD PhD

Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.

Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

St. Olavs Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer	NCT00748358	Prostatic Neopl... Neoplasms, Horm... Tumor Markers, ... Survival Rate Disease-Free Su...	sunitinib	18 Years -	Assistance Publique - Hôpitaux de Paris
An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer	NCT00748358	Prostatic Neopl... Neoplasms, Horm... Tumor Markers, ... Survival Rate Disease-Free Su...	sunitinib	18 Years -	Assistance Publique - Hôpitaux de Paris
Molecular Markers in Treatment in Endometrial Cancer	NCT00598845	Endometrial Neo... Neoplasm Metast...	Tumor biopsy st...	-	University of Bergen
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma	NCT01821196	Stomach Neoplas...	biopsy	-	St. Olavs Hospital
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma	NCT01821196	Stomach Neoplas...	biopsy	-	St. Olavs Hospital

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