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Docetaxel and Capecitabine in Advanced Gastric Cancer

Primary Purpose

Stomach Neoplasm, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Docetaxel
Capecitabine
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring gastric cancer, metastatic, locally advanced, docetaxel, capecitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with histologically proven adenocarcinoma of the stomach or the GE-junction. 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: Karnofsky-performance-index less or equal 50%. 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.

Sites / Locations

  • Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Median Survival
Time to Tumor Progression
Toxicity
Quality of Life

Full Information

First Posted
September 1, 2005
Last Updated
April 17, 2007
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00142038
Brief Title
Docetaxel and Capecitabine in Advanced Gastric Cancer
Official Title
Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

Brief Summary
Up to date there is no worldwide accepted standard chemotherapy for the 1st-line treatment of advanced or metastatic gastric cancer.A combination of epirubicin, cisplatin and 5-FU (ECF) is the best examined combination and widely used. Recent studies (Thuss-Patience et al, J. Clin. Oncol. 2005) could show that a combination of docetaxel and 5-FU might be similarly effective as ECF. 5-FU and docetaxel +/- cisplatin combinations are investigated by many groups and may be a future reference treatment. Many data suggest that 5-FU infusion can be replaced by oral capecitabine with equal efficacy. 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
Patients with locally advanced or metastatic gastric adenocarcinoma who did not receive any prior chemotherapy for advanced disease can be enrolled in the study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Neoplasm Metastasis
Keywords
gastric cancer, metastatic, locally advanced, docetaxel, capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
Response Rate
Secondary Outcome Measure Information:
Title
Median Survival
Title
Time to Tumor Progression
Title
Toxicity
Title
Quality of Life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically proven adenocarcinoma of the stomach or the GE-junction. 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: Karnofsky-performance-index less or equal 50%. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P Reichardt, MD, PhD
Organizational Affiliation
Charité, University, Campus-Virchow-Klinikum, Dept. of Hematology and Oncology, Berlin,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P C Thuss-Patience, MD, PhD, Msc
Organizational Affiliation
Charité, University, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15659494
Citation
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.
Results Reference
background
Links:
URL
http://www.charite.de
Description
Charité University Clinic, Berlin

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Docetaxel and Capecitabine in Advanced Gastric Cancer

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