Phase I/II study of Taxotere® (docetaxel), Eloxatin® (oxaliplatin) and Xeloda® (capecitabine) as first line treatment to patients with non-resectable ventricular cancer and/or distal esophageal cancer - TEX

Phase 1

• Conditions: Patients with histological proven adenocarcinoma of the stomach and/or esophageal gastric junction

• Registration Number: EUCTR2006-002270-21-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-20
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Phase I:

1. Histological proven adenocarcinoma of the stomach and/or esophageal gastric junction (distal 2 cm of oesophagus)
2. Age = 18 years
3. WHO performance status 0-1
4. Life expectancy of more than 3 months
5. Adequate haematological function: ANC = 1.5 x 109/L, platelets = 100 x 109/L
6. Adequate renal and hepatic function: total bilirubin = 1.5 x upper normal limit, ASAT and/or ALAT = 3 x upper normal limit, no upper limit in case of liver metastases
7. Creatinine clearance = 30 ml/min.
8. First treatment day planned within 8 days after randomization
9. Written informed consent prior to randomization

Phase II:

Same as phase I AND
1. Measurable lesion according to RECIST

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Phase I and II:

1. Prior chemotherapy > 6 months before inclusion
2. Neuropathy
3. Prior treatment with Taxotere, Oxaliplatin or Xeloda
4. Past or concurrent history of malignant neoplasm except for non-melanoma skin cancer
5. Evidence of brain metastases
6. Concomitant administration of any other experimental drug or within 14 days before inclusion
7. Other serious illness or medical conditions (e.g.: myocardial infarction, infection)
8. Pregnant or lactating women
9. Known allergy towards taxanes, 5-FU or platinum
10. Patients who cannot take oral medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase I: To determine max. tolerable dose (MTD) for the combination regime docetaxel, oxaliplatin and capecitabine (TEX) as first line treatment to patients with primary or recurrent non-resectable cancer of the stomach<br><br>Phase II: To estimate response rate for treatment with TEX as first line treatment to patients with primary or recurrent non-resectable cancer of the stomach;Secondary Objective: Phase I: To estimate toxicity for the TEX-regime and to determine the dose level for the regime for phase II<br><br>Phase II: To evaluate time to progression (TTP), overall survival and toxicity ;Primary end point(s): Phase I: to determine maximum tolerable dose (MTD) for the combination regimen of docetaxel, oxaliplatin and capecitabine (TEX) as first line treatment for patients with primary or recurrent non-resectable gastric cancer<br><br>Phase II: to evaluate response rate for the TEX-regime as first line treatment for patients with primary or recidual non-resectable gastric cancer<br><br>