Docetaxel and Capecitabine in Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Capecitabine; Docetaxel

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.