Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer

NCT00004873 | Completed Phase 2

• 3 other identifiers: SAKK 42/99SWS-SAKK-42/99EU-99021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating advanced stomach cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of combination chemotherapy in treating patients who have advanced stomach cancer.

Conditions

Gastric Cancer

Keywords

stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer

Interventions

cisplatin DRUG

docetaxel DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed gastric carcinoma not amenable to curative surgery or in relapse after primary surgical resection * Locally advanced disease (i.e., measurable locoregional lymph nodes) OR * Metastatic disease * Bidimensionally measurable disease * At least 10 mm X 20 mm by chest x-ray or physical examination * At least 10 mm X 10 mm by CT scan * No CNS metastasis PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * 0-1 Life expectancy: * Greater than 12 weeks Hematopoietic: * WBC count at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 5 times ULN Renal: * BUN normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No severe hypercalcemia Cardiovascular: * No unstable cardiac disease requiring treatment * No congestive heart failure * No angina pectoris even if medically controlled * No significant arrhythmias * No prior myocardial infarction unless ejection fraction at least 50% by MUGA scan or echocardiogram Neurologic: * No prior significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would preclude study * No peripheral neuropathy of any origin (alcohol, etc.) greater than grade 1 Other: * Fertile patients must use adequate contraception * No prior malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix * No active uncontrolled infection * No other serious illness or medical condition that would preclude study participation * No contraindication to corticosteroid use PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior palliative chemotherapy * At least 12 months since prior adjuvant or neoadjuvant chemotherapy * No prior taxanes * Prior fluorouracil allowed in bolus form only * Prior cumulative dose of adjuvant or neoadjuvant cisplatin no greater than 300 mg/m2 Endocrine therapy: * Prior or concurrent prednisone (or equivalent) allowed for prophylaxis, acute hypersensitivity reactions, or chronic therapy (greater than 6 months) at doses no greater than 20 mg Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No other concurrent experimental drugs * No other concurrent anticancer therapies * At least 30 days since treatment in prior clinical trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (1)

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Related Publications (1)

• Roth AD, Fazio N, Stupp R, Falk S, Bernhard J, Saletti P, Koberle D, Borner MM, Rufibach K, Maibach R, Wernli M, Leslie M, Glynne-Jones R, Widmer L, Seymour M, de Braud F; Swiss Group for Clinical Cancer Research. Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol. 2007 Aug 1;25(22):3217-23. doi: 10.1200/JCO.2006.08.0135.

  PMID: 17664469 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cisplatin; Docetaxel; Epirubicin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arnaud Roth, MD

  Hopital Cantonal Universitaire de Geneve

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 1999
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

CH (1)