Neoplasm Metastasis Clinical Trial
Official title:
Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Thuss-Patience PC, Kretzschmar A, Repp M, Kingreen D, Hennesser D, Micheel S, Pink D, Scholz C, Dörken 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | |||
Secondary | Median Survival | |||
Secondary | Time to Tumor Progression | |||
Secondary | Toxicity | |||
Secondary | Quality of Life |
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