Docetaxel and Capecitabine in Advanced Gastric Cancer

NCT00142038 | Completed Phase 2

• 1 other identifier: AGST-Magen-CapDoc-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasm; Neoplasm Metastasis

Keywords

gastric cancer; metastatic; locally advanced; docetaxel; capecitabine

Outcome Measures

Primary Outcomes (1)

• Response Rate

Secondary Outcomes (4)

• Median Survival

• Time to Tumor Progression

• Toxicity

• Quality of Life

Interventions

Docetaxel DRUG

Capecitabine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 15659494 BACKGROUND

Related Links

• Charité University Clinic, Berlin

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: March 1, 2004
• Study Completion: December 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

DE (1)