Status:
COMPLETED
Docetaxel and Capecitabine in Advanced Gastric Cancer
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Stomach Neoplasm
Neoplasm Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ex...
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 capeci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00142038
Start Date
March 1 2004
End Date
December 1 2007
Last Update
April 18 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology
Berlin, Germany, 13353