Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Carboplatin

Docetaxel

Cisplatin

Mitogens

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antimetabolites

Tyrosine

Erlotinib (Tarceva)150 mg /day

Patients will receive treatment until disease progression or unacceptable toxicity.

For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

4 cycles of Chemotherapy:

Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.

- Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v.

day 1. Repeat cycles every 3 weeks.

- Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks.

In the case of patients not eligible for treatment with cisplatin, cisplatin can be replaced by carboplatin. The schedules will be the following:

Docetaxel 75 mg/m2 day 1 and carboplatin AUC = 6 day 1, every 21 days.

Gemcitabine 1000 mg/m2 days 1 and 8 and carboplatin AUC = 5 day 1, every 21 days.

Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.

For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

Erlotinib

Gemcitabine 1000 mg/m2 days 1 and 8 and Carboplatin AUC = 5 day 1, every 21 days.

Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)

Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Gemcitabin

Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Rafael Rosell i Costa, MD

Luis Paz-Ares, MD

A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

This is a multicenter, phase III, randomized, open-label clinical trial.

146 patients with a diagnosis of advanced (stage IIIB and stage IV), non-squamous-cell, non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor, EGFR will be recluted.

The primary objective is to compare the progression-free survival in both treatment arms of the study (conventional chemotherapy vs. erlotinib) in patients with non-squamous-cell, non-small-cell lung cancer (NSCLC) in advanced stage (stages IIIB and stage IV) who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR).

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)

The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria.

Proportion of patients who are still alive one year after enrollment in the study.

Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.

Occurrence and severity of adverse events, with severity determined by NCI CTCAE v3.0 criteria

Changes in the scores obtained with the LCSS validated questionnaire throughout the course of the study will be analyzed to assess change in the patient's quality of life.

The study of mutations in serum (serum DNA)

Spanish Lung Cancer Group

Symptoms and General Pathology

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Disease Attributes

Central Nervous System Depressants

Anesthetics

Paclitaxel

Albumin-Bound Paclitaxel

Nivolumab

After local anaesthesia, intratumoral catheter will be place (one or several depending tumour criteria).The catheter placement could be guided by radiological imaging. Gemcitabine (200mg/l), carboplatin (100mg/l) and paclitaxel (20mg/l) will be each diluted in each in 160ml of NaCl0.9%. GCP will be administered successively for 8hours, at 20ml/h with a total duration of 24hours. The ITC will be done every 28 days for 6 times maximum in case of good response and tolerance. Nivolumab 240 mg IV will be started 1 to 7 days before the first intratumoral infusion and every 15 days, until progression or 2 until years in case of partial response, complete response or stabilization. Evaluation of tumour size will be done by CT-scan, or MRI 2every 2 months and PET-FDG every 3 months.

GCP intratumoral catheter

Aline HOUESSINON, MD

Bruno CHAUFFERT, Pr

Aurelie MOREIRA, MD

Stéphanie DAKPE, Pr

Jérémie BETTONI, MD

Bernard DEVAUCHELLE, Pr

Sylvie TESTELIN, Pr

Aurelie BIET, MD

Cyril PAGE, Pr

Alexandre COUTTE, MD

Antoine GALMICHE, PR

Michel LEFRANC, Pr

Jean Marc CONSTANS, Pr

Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.

Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.

The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.

Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

RECIST is a standard way to measure the response of a tumor to treatment. The criteria to determine whether a tumor disappears, shrinks, are complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

Evaluation of target lesions

* Complete Response (CR): Disappearance of all target lesions
* Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
* Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
* Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Evaluation of non-target lesions
* Complete Response (CR): Disappearance of all non-target lesions and no

Centre Hospitalier Universitaire, Amiens

Digestive System Diseases

Gland and Hormone Related Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Rare Diseases

Pancreatic Neoplasms

Adenocarcinoma

Acquired Immunodeficiency Syndrome

HIV Infections

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Anti-Infective Agents

Cobicistat

Antiviral Agents

Anti-Retroviral Agents

Cytochrome P-450 CYP3A Inhibitors

Anti-HIV Agents

Cytochrome P-450 Enzyme Inhibitors

CYP3A Inhibitor Cobicistat and the cytostatics Gemcitabine and nab-Paclitaxel

Cobicistat Oral Tablet

Nab paclitaxel

Nicolas Hohmann, PD Dr. med.

Nicolas Hohmann, PD. Dr. med

To explore the possibility to overcome CYP3A-mediated resistance to anticancer drugs in pancreatic cancer, we will investigate the pharmacokinetics, safety, tolerability, and efficacy of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine and the CYP3A inhibitor cobicistat in a phase I proof-of-concept trial to determine the safety profile, the recommended dose of nab-paclitaxel in combination with gemcitabine and cobicistat, and to determine whether there is an early efficacy signal warranting a larger scale trial.

The present trial is an open-label trial consisting of a dose-escalation part and an expansion part. The dose escalation part is designed to determine the safety, tolerability, and pharmacokinetics of nab-paclitaxel in combination with gemcitabine and cobicistat and will guide the dosing in the expansion part of the trial.

The trial enrolls patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma and adequate performance score (ECOG PS 0-2) who would usually receive gemcitabine and nab-paclitaxel according to standard of care.

Primary endpoint for the phase I trial is the safety of the combination. Overall survival (OS), disease control rate (DCR), overall response rate (ORR), duration of response (DoR) and progression free survival (PFS) are secondary efficacy endpoints. Further secondary endpoints are tolerability, pharmacokinetics, pharmacodynamics, and pharmacogenomics.

A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma

IntenSify: An Open-label Phase I Trial of the CYP3A Inhibitor Cobicistat and the Cytostatics Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma to Evaluate the Combination's Pharmacokinetics, Safety and Efficacy

occurrence of DLTs within treatment cycle 1

University Hospital Heidelberg

German Cancer Research Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR	NCT00446225	Non-Small Cell ...	Erlotinib Carboplatin Gemcitabin Docetaxel Cisplatin	18 Years -	Spanish Lung Cancer Group
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers	NCT05835804	Squamous Cell C... Paclitaxel Carboplatin Nivolumab	GCP intratumora...	18 Years -	Centre Hospitalier Universitaire, Amiens
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma	NCT05494866	CYP3A Inhibitor Advanced Stage ... Pancreatic Canc... Pancreatic Aden... Pancreatic Neop...	Cobicistat Oral... Gemcitabin Nab paclitaxel	18 Years -	German Cancer Research Center
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma	NCT05494866	CYP3A Inhibitor Advanced Stage ... Pancreatic Canc... Pancreatic Aden... Pancreatic Neop...	Cobicistat Oral... Gemcitabin Nab paclitaxel	18 Years -	German Cancer Research Center
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers	NCT05835804	Squamous Cell C... Paclitaxel Carboplatin Nivolumab	GCP intratumora...	18 Years -	Centre Hospitalier Universitaire, Amiens

Spots Global Cancer Trial Database for gemcitabin

Every month we try and update this database with for gemcitabin 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 gemcitabin

Every month we try and update this database with for gemcitabin 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 gemcitabin 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.