Docetaxel and Capecitabine in Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00142038
First received: September 1, 2005
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasm
Neoplasm Metastasis
Drug: Docetaxel
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Response Rate

Secondary Outcome Measures:
  • Median Survival
  • Time to Tumor Progression
  • Toxicity
  • Quality of Life

Estimated Enrollment: 80
Study Start Date: March 2004
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142038

Locations
Germany
Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: P Reichardt, MD, PhD Charité, University, Campus-Virchow-Klinikum, Dept. of Hematology and Oncology, Berlin,
Principal Investigator: P C Thuss-Patience, MD, PhD, Msc Charité, University, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00142038     History of Changes
Other Study ID Numbers: AGST-Magen-CapDoc-04
Study First Received: September 1, 2005
Last Updated: April 17, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
gastric cancer
metastatic
locally advanced
docetaxel
capecitabine

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014