Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer

Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer

Combination regimens of 3 active drugs have shown promising activity in treatment of metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded superior overall survival and response rates when compared to standard cisplatin and 5-FU. However, a toxicity profile showed the need for development of less toxic modifications. In a prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first evaluation of activity will be performed.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Drug: docetaxel, oxaliplatin, capecitabine

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Bochum, Germany, 44892
    • Medizinische Universitätsklinik - Knappschaftskrankenhaus
  • Esslingen, Germany, 73730
    • Städtische Kliniken Esslingen
  • Fulda, Germany, 36043
    • MVZ Osthessen
  • Halle (Saale), Germany, 06120
    • Martin-Luther-University Halle-Wittenberg
  • Leipzig, Germany, 04129
    • Städt. Klinikum St. Georg
  • Lörrach, Germany, 79539
    • OSP Lörrach-Rheinfelden
  • Mainz, Germany, 55101
    • Universitätsklinikum Mainz
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim
  • Ulm, Germany, 89081
    • Universitätsklinik Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Histologically proven irresectable, metastatic or recurrent adenocarcinoma of the stomach or the gastroesophageal junction, i.e., Tx-4 M1 or T4 M0

• Irresectable (as judged by an experienced surgeon):

  1. T4 infiltrating of several organs
  2. T4 infiltrating one organ, but irresectable
  3. T4 infiltrating one organ, respectable, but inoperable patient
• The nodal status is neglected
• Measurable disease according to RECIST
• ECOG Performance Status ≤ 2
• Male or female patients aged ≥ 18 years
• Life expectancy ≥ 3 months

• Adequate bone marrow, hepatic and renal function:

  1. Haemoglobin > 9.0 g/dL (transfusions allowed to achieve or maintain levels)
  2. Absolute neutrophil count > 1.5 x 10^9/L
  3. Platelet count > 100 x 10^9/L
  4. ALAT, ASAT < 3.5 x ULN
  5. Alkaline phosphatase < 6 x ULN
  6. Total bilirubin < 1.0 x ULN
  7. Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
• Prior surgery must be more than 28 days ago
• Positive nodes as diagnosed on endorectal ultrasound and/or MRI (tumour is staged by preferably a high resolution MRI; if MRI is not available, locoregional staging must be performed by computed tomography plus endorectal ultrasound)
• Tumor staging must be done within 28 days from the start of the treatment

• Negative pregnancy test in women with childbearing of potential (within 7 days prior to the start of the chemotherapy)

  • Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria:

• Prior cytotoxic chemotherapy or radiotherapy (a neoadjuvant or adjuvant chemotherapy must be completed and without progression for at least 6 months)
• Previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
• Peripheral neuropathy ≥ grade 2 (according to NCI CTCAE v 3.0)
• Patient must not have been treated with any investigational drug, agent nor procedure, (i.e., did not participate in another trial within 30 days) before entry in this trial
• Known allergy or any other adverse reaction to any of the study drugs or to any related compound
• Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine

• Clinically significant concomitant diseases, such as:

  1. Active infection necessitating systemic antibiotics
  2. Interstitial lung diseases
  3. Chronic diarrhea, inflammatory bowel disease
  4. Neurological or psychiatric disease, dementia, epilepsy or untreated brain metastases
• Cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction or resuscitation within the last 6 months
• Pregnant or lactating women are excluded
• Presence of adequate contraception in fertile patients (methods of adequate contraception are: intra-uterine device, hormonal contraception, vasectomy, tubal ligation or abstinence)
• Alcohol or drug abuse
• Ability to swallow tablets
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; docetaxel, oxaliplatin, capecitabine	Drug: docetaxel, oxaliplatin, capecitabine; Docetaxel: 35 mg/m2, IV day 1, 8 of each 21 day cycle; Oxaliplatin: 70 mg/m2, IV day 1, 8 of each 21 day cycle; Capecitabine: 2x800 mg/m2 PO IV day 1 evening till morning of day 15 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.; Other Names: taxotere; eloxatin; xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival rate	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate	2 years
Duration of response	2 years
Time to treatment failure	2 years
Median overall survival	2 years
Median time to progression	2 years
Number of Participants with Adverse Events as a Measure of Safety/toxicity	2 years
Rate of resections with curative intent	2 years

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Investigators: Principal Investigator: Hans-Joachim Schmoll, Prof. Dr., Martin-Luther-University Halle-Wittenberg, Medical Faculty

Publications and helpful links

Helpful Links

• Arbeitsgemeinschaft Internistische Onkologie

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 2, 2007
• First Submitted That Met QC Criteria: August 2, 2007
• First Posted (Estimate): August 3, 2007

Study Record Updates

• Last Update Posted (Estimate): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: capecitabine; oxaliplatin; docetaxel; Stomach neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine; Oxaliplatin
• Other Study ID Numbers: AIO STO-0601