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Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Stomach Neoplasm, Neoplasm Metastasis

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Trial Information

Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer

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.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Principal Investigator

P Reichardt, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2004

Completion Date:

December 2007

Related Keywords:

  • Stomach Neoplasm
  • Neoplasm Metastasis
  • gastric cancer
  • metastatic
  • locally advanced
  • docetaxel
  • capecitabine
  • Neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis