Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Pharmaceutical Solutions

Vasoconstrictor Agents

Respiratory System Agents

Docetaxel

Oxaliplatin

Dexamethasone

Epinephrine

Dexamethasone acetate

Racepinephrine

Epinephryl borate

Maleic acid

Tubulin Modulators

Antimitotic Agents

1. Treatment Schedule

1.1. Docetaxel schedule Docetaxel 35 mg/m2 is administered on day 1 and day 8 by intravenously in 100 mL of 5% dextrose solution over 30 minutes. Dexamethasone 8mg is intravenously administered before 30 minutes, and then orally 4mg every 12 hours over 48 hours. In the event of a hypersensitivity reaction, dimethidine maleate, epinephrine, and intravenous fluids will be required.

1.2. Oxaliplatin schedule Oxaliplatin 100 mg/m2 is given on day 1 by intravenous infusion in 500 mL of 5% dextrose solution over 120 minutes. Therapy will be repeated every 21 days.

Docetaxel, Oxaliplatin

Eun Ki Song

Hwan Jung Yun

1. Goals

   * The primary goal of this phase II trial is to:

   evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy

   Secondary goals are to:evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
2. Design

The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon.22

Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer

Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Number and proportion of patients with adverse events according to the NCI-CTCAE (v 4.0) as a measure of treatment-related toxicities

Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves.

The median PFS and OS will be used for measure.

Korean South West Oncology Group

Esophageal Neoplasms

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Radiotherapy

Markus Moehler, MD

The purpose of this study is to determine the dose limiting toxicity and the maximum tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with adenocarcinoma of the gastric-oesophageal junction.

Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and Oxaliplatin and will be administered in single doses of 1.8 Gy once daily and five times a week for 5 weeks.

In the sixth treatment week a boost of 3 further radiations with 1.8 Gy will be applied.

Simultaneous chemotherapy:

Initially, in part A of the study the maximum tolerable dose (MTD) for the simultaneous chemotherapy will be identified with a 3-step dose escalation scheme:

Level 1: Docetaxel: 20 mg/m2 Oxaliplatin 40 mg/m2 i.v., Level 2: Docetaxel: 20 mg/m2 Oxaliplatin 50 mg/m2 i.v., Level 3: Docetaxel: 25 mg/m2 Oxaliplatin 50 mg/m2 i.v.,

The treatment starts with 3 patients in level 1. If no dose limiting toxicities appear, it will be switched to dose level 2. The same applies for the switch from level 2 to level 3. If a DLT appears on one level, a further 3 patients will be treated within this dose level.

If in one level at least 2 of 6 patients show DLT, the subjacent level will be defined as the maximum tolerable dose (MTD).

Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction

Prospective, Open, Multicentre Phase I/II Study to Evaluate the Safety and Efficacy of a Neoadjuvant Radiochemotherapy With Docetaxel and Oxalipaltin in Patients With Adenocarcinoma of the Gastric-oesophageal Junction

Johannes Gutenberg University Mainz

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer	NCT01234051	Biliary Tract C...	Docetaxel, Oxal...	18 Years -	Korean South West Oncology Group
Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction	NCT00374985	Esophageal Neop... Stomach Neoplas...	Docetaxel, Oxal... Radiotherapy	18 Years - 75 Years	Johannes Gutenberg University Mainz

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