Docetaxel and Capecitabine in Advanced Gastric Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasm Neoplasm Metastasis |
Drug: Docetaxel Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer |
- Response Rate
- Median Survival
- Time to Tumor Progression
- Toxicity
- Quality of Life
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Germany | |
| Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology | |
| Berlin, Germany, 13353 | |
| Principal Investigator: | 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 |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00142038 History of Changes |
| Other Study ID Numbers: | AGST-Magen-CapDoc-04 |
| Study First Received: | September 1, 2005 |
| Last Updated: | April 17, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
gastric cancer metastatic locally advanced docetaxel capecitabine |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Neoplastic Processes Pathologic Processes Docetaxel |
Capecitabine Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013