COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Docetaxel and Capecitabine in Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142038
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 18, 2007
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasm Neoplasm Metastasis Drug: Docetaxel Drug: Capecitabine Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. Response Rate

Secondary Outcome Measures :
  1. Median Survival
  2. Time to Tumor Progression
  3. Toxicity
  4. Quality of Life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142038

Layout table for location information
Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Layout table for investigator information
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

Additional Information:
Layout table for additonal information Identifier: NCT00142038    
Other Study ID Numbers: AGST-Magen-CapDoc-04
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007
Keywords provided by Charite University, Berlin, Germany:
gastric cancer
locally advanced
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Stomach Neoplasms
Neoplastic Processes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic