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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511446
• Other study ID #: AIO STO-0601
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2007
• Last updated: June 25, 2013
• Start date: August 2007
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Charite - Universitatsmedizin Berlin	Berlin
Germany	Medizinische Universitätsklinik - Knappschaftskrankenhaus	Bochum
Germany	Städtische Kliniken Esslingen	Esslingen
Germany	MVZ Osthessen	Fulda
Germany	Martin-Luther-University Halle-Wittenberg	Halle (Saale)
Germany	Städt. Klinikum St. Georg	Leipzig
Germany	OSP Lörrach-Rheinfelden	Lörrach
Germany	Universitätsklinikum Mainz	Mainz
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Universitätsklinik Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate		at 6 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety/toxicity		2 years	Yes
Secondary	Median time to progression		2 years	Yes
Secondary	Response rate		2 years	Yes
Secondary	Rate of resections with curative intent		2 years	Yes
Secondary	Time to treatment failure		2 years	Yes
Secondary	Duration of response		2 years	Yes
Secondary	Median overall survival		2 years	Yes

External Links

•   Arbeitsgemeinschaft Internistische Onkologie