Neoplasms

All Conditions

Rare Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Sorafenib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.

Placebo

Markus Moehler, MD

This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the role of sorafenib in combination with gemcitabine in advanced CCC.

Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β.

Mutations in these signaling pathways display by far the most common genetic alterations in CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine, suggesting that sorafenib can safely be combined with gemcitabine.

Clinical results of a combination of sorafenib and gemcitabine in a phase I study in pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results together with the knowledge of the molecular pathology of CCC provide a rationale for a randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in advanced CCC.

Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)

A Randomized, Double-blind, Multicenter Phase II Trial With Gemcitabine Plus Sorafenib Versus Gemcitabine Plus Placebo in Patients With Chemo-naive Advanced or Metastatic Adenocarcinoma of the Biliary Tract

The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.

Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.

Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks.

Two objective status determinations of CR before progression are required for a best response of CR.

Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR.

Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment.

Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.

Johannes Gutenberg University Mainz

Interdisciplinary Center for Clinical Trials (IZKS)

PD Dr Markus Möhler

Gemcitabine + Sorafenib

Sorafenib : Sorafenib 400 mg bid orally continuously

Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.

Gemcitabine + Sorafenib

Gemcitabine + Placebo

Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.

Placebo : Placebo

Gemcitabine + Placebo

Total

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Germany

Region of Enrollment

Adeno carcinoma, gall bladder

Adeno carcinoma, intrahepatic bile ducts

Adeno carcinoma, hepatic metastases

Type of Adenocarcinoma

1 (well differentiated)

2 (moderately differentiated)

3 (poorly differentiated)

4 (undifferentiated)

Missing

Grading of adenocarcinoma

is defined as difference between date of first histological diagnosis and date of first visit

Time since histological diagnosis

ECOG Performance Status

Number of target lesions

Number of non-target lesions

Sum Sizes of target lesions

A. Kaiser

All subjects who receive at least one dose of trial treatment are included in the analysis.

Progression-free Survival (PFS)

All subjects who receive at least one dose of trial treatment are included in the analysis

Overall Survival

Complete response

Partial response

Stable disease

Progressive disease

Best Overall Response

All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis

Time to Objective Response

Overall Study

Carcinoma, Transitional Cell

Cisplatin

Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance \< 60ml/min)

+ best suportive care, with regards clinical practice.

Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance \< 60ml/min).

Vinflunine

All the current interventions used by each institution for the study disease.

Undefined (standard care)

Jesús García-Donas, MD

Albert Font, MD

Joaquim Bellmunt, MD

This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine administered after the standard treatment of the combination gemcitabine+cisplatin, when it has reached stabilization or response of the disease, as the first treatment inmeditely after the diagnosis of advanced or metastatic urothelial cancer.

Vinflunine is a drug recently approved in Europe for the treatment of advanced or metastatic urothelial cancer after platinum-failure. It has proved to improve the survival results compared with the best suportive care. In adition, the tolerability was favourable, specially for not leading appearance of neuropathy nor other cumulative toxic effects.

In this study, it is proposed to test the feasibility, in terms of tolerability and efficacy of monotherapy with vinflunine in patients who, after completing the first-line cisplatin-based treatment for Transitional Cell Carcinoma of the Urothelial Tract (CCTU), have reached a stabilization or objective response. In order to have an adequate control group in the proposed design will be a phase II trial in which one group will receive standard management (follow-up until progression disease).

Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer

Randomized Phase II Study of Vinflunine as Maintenance Monotherapy in Patients With Advanced or Metastatic Urothelial Cancer That Obtains Clinical Benefit of the First Line With Cisplatin-gemcitabine Combination

To evaluate the Progression Free Survival (PFS) with vinflunine in maintenance monotherapy in patients with advanced or metastatic CCTU that has reached stabilization or objective response after completing 6 cycles with the combination cisplatin-gemcitabine in 1st line.

Spanish Oncology Genito-Urinary Group

Digestive System Diseases

Cholangiocarcinoma

Biliary Tract Neoplasms

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Bile Duct Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Vandetanib 300 mg as a once daily oral dose, from Day 1

Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)

Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).

300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

ZD6474, Vandetanib

100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo matching ZD6474

Clinical Sciences & Operations

The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.

Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)

Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).

Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD

DCR is the sum of patients with a best overall CR, PR or SD (\>=8 weeks) by the patient in the analysis

DOR is defined from the date of first documentation of response until date of PD or death

OS is defined from the date of randomization to death

Genzyme, a Sanofi Company

Arm A Vandetanib 300 mg

Arm B Vandetanib 100mg + Gemcitab

ARM C Placebo+ Gemcitabine

Age, Continuous

Patient screened 180 Patient Randomized 174 (1 never treated) Sceening failures 6 Patient Treated 173 (ITT=165 ; 8 excluded from ITT due to missing postbaseline assesment)

Trial Transparency Team

Progression Free Survival

Objective Response = NO

Objective Response = YES

Objective Tumor Response Rate (CR+PR),

Disease control rate = NO

Disease control rate = YES

Disease Control Rate (CR+PR+SD)

Duration of Response (DOR)

A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients

neck dissection of at least the ipsilateral sub-level 1B

Thomas Robbins, M.D.

Hypothesis

1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it.
2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.

Study Design

A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.

Hypothesis

1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it.
2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.

Study Design

1. A prospective controlled study.
2. A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. In case of oral cavity tumors, about 15 minutes prior to the surgery, 1ml of Lymphazurin® blue dye will be injected in 4 quadrants around the primary site. The dissection will be performed in 3 stages. In the first stage all lymph node groups that lie either lateral, anterior, posterior, superior, or inferior to the submandibular gland, but within anatomical boundaries of level 1B, will be dissected. The submandibular gland will be left intact for this portion of the procedure. Next, the submandibular gland will be removed. Lastly, any remaining fibrofatty tissue that lies deep to the submandibular gland within the confines of level IB will be removed. Each lymph node group, the submandibular gland, and the fibrofatty tissue lying deep to the submandibular gland, will be submitted for pathological assessment in separate containers.
3. The following end-points will be measured: the number of lymph nodes identified within each lymph node group, the number of lymph nodes located within the submandibular gland, and the number of lymph nodes within the fibrofatty contents lying deep to the submandibular gland. The presence or absence of carcinoma within each of the assessed nodes will be documented, as well as extracapsular spread.

A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.

Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients

Prospective Study to Assess the Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Patients With Carcinoma of the Upper Aerodigestive Tract

The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.

Pathological detection of carcinoma within each of the dissected nodes reported as node groups.

Southern Illinois University

A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.

Surgery

<=18 years

Between 18 and 79 years

>=80 years

Age, Customized

Not completed

submandibular gland excision

sublevel IB dissection

surgical bed inspection

Director of Clinical Trials

Preglandular nodal group-Right neck

Prevascular nodal group-Right neck

Retrovascular nodal group-Right neck

Retroglandular nodal group-Right neck

Preglandular nodal group-Left neck

Prevascular nodal group-Left neck

Retrovascular nodal group-Left neck

Retroglandular nodal group-Left neck

Submandibular nodes (Right or Left)

Nodes Deep to Submandibular gland (Right or Left)

A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.

Surgical Lymph Node Groups

the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)	NCT00661830	Adenocarcinoma	Gemcitabine Placebo Sorafenib	18 Years -	Johannes Gutenberg University Mainz
Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer	NCT01529411	Carcinoma, Tran...	Vinflunine Undefined (stan...	18 Years - 80 Years	Spanish Oncology Genito-Urinary Group
Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer	NCT01529411	Carcinoma, Tran...	Vinflunine Undefined (stan...	18 Years - 80 Years	Spanish Oncology Genito-Urinary Group
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	NCT00753675	Biliary Tract C... Gallbladder Can... Cancer Of The E... Ampullary Carci...	ZD6474, Vandeta... ZD6474, Vandeta... Gemcitabine Placebo matchin...	18 Years -	Sanofi
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients	NCT00728130	Carcinoma	neck dissection...	18 Years -	Southern Illinois University
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	NCT00753675	Biliary Tract C... Gallbladder Can... Cancer Of The E... Ampullary Carci...	ZD6474, Vandeta... ZD6474, Vandeta... Gemcitabine Placebo matchin...	18 Years -	Sanofi

Spots Global Cancer Trial Database for tract

Every month we try and update this database with for tract cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tract

Every month we try and update this database with for tract cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tract cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.