Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2004-03-31
2007-12-31
Brief Summary
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As docetaxel/5-FU is probably similarly effective as epirubicin/cisplatin/5-FU and a replacement of 5-FU infusion by capecitabine makes the chemotherapy more comfortable for the patient we investigate in this study a chemotherapy of docetaxel and capecitabine as 1st-line therapy for metastatic or advanced gastric cancer.
Detailed Description
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Patients are treated with oral capecitabine 1000mg/sqm twice per day on the days 1-14 and docetaxel 75 mg/sqm on day 1 as a 1 hour i.v. infusion. chemotherapy is repeated every 21 days. Staging by imaging is performed every 2 cycles.
After 40 included patients an amendment was done and the starting of chemotherapy has been reduced to further improve tolerability. Starting dose of docetaxel was amended to 60 mg/sqm, d1, and starting dose of capecitabine reduced to 800 mg/sqm twice per day, d1-14. The patient number to be included was increased to 70 pts.
Therapy is continued up to tumor progression to a maximum of 10 cycles. Therapy is stopped in case of severe side effects, tumor progression or withdrawal of consent.
This investigator initiated study is supported by Hoffmann-La Roche and by Sanofi-Aventis.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Docetaxel
Capecitabine
Eligibility Criteria
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Inclusion Criteria
* Patients with distant metastases or patients with locally advanced disease who are not curatively operable proven by laparoscopy or patients with a recurrence after gastrectomy.
* Patients who did not receive any prior palliative chemotherapy. An adjuvant chemotherapy is allowed.
* Age between 18 and 75 years.
* Sufficient bone marrow function defined as leucocytes \> 3.0 Gpt/l, thrombocytes \> 100 Gpt/l
* Sufficient liver function defined as bilirubin \< 1.5 mg/dl (1.5 x ULN), ALT and AST \< 3 x ULN.
* Sufficient renal function defined as serum creatinine \< 1.25 x ULN, or creatinine clearance \> 60 ml/min calculated according to Cockroft-Gault
* Contraception in patients with reproductive potential.
* Karnofsky-performance-index at least 60%
* Measurable tumor lesions.
* Written informed consent of the patient.
Exclusion Criteria
* Patients who already received a palliative first-line chemotherapy.
* Prior second malignancy, except basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix.
* Parallel radiation therapy
* Uncontrolled infection.
* CNS-metastasis
* Other severe medical disease
* Prior major surgery for less than 2 weeks
* Parallel treatment with other experimental therapies.
* Parallel treatment with any other therapy aiming against the tumor.
* Chronic diarrhea, subileus.
* Chronic inflammatory bowel disease or intestinal obstruction.
* Unable to take oral medication.
* Pregnancy or breast feeding.
18 Years
75 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Principal Investigators
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P Reichardt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Charité, University, Campus-Virchow-Klinikum, Dept. of Hematology and Oncology, Berlin,
P C Thuss-Patience, MD, PhD, Msc
Role: PRINCIPAL_INVESTIGATOR
Charité, University, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
Locations
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Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
Berlin, , Germany
Countries
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References
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Thuss-Patience PC, Kretzschmar A, Repp M, Kingreen D, Hennesser D, Micheel S, Pink D, Scholz C, Dorken B, Reichardt P. Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. J Clin Oncol. 2005 Jan 20;23(3):494-501. doi: 10.1200/JCO.2005.02.163.
Related Links
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Charité University Clinic, Berlin
Other Identifiers
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AGST-Magen-CapDoc-04
Identifier Type: -
Identifier Source: org_study_id