Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00004873
First received: March 7, 2000
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Taxotere-Cisplatin-5FU (TCF) Versus Taxotere-Cisplatin (TC) Versus Epirubicin-Cisplatin-5FU (ECF) as Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Study Start Date: August 1999
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the efficacy and tolerability of docetaxel, cisplatin, and fluorouracil (TCF) versus docetaxel and cisplatin (TC) versus epirubicin, cisplatin, and fluorouracil (ECF) in patients with advanced gastric carcinoma.
  • Compare the time to treatment failure, time to progression, and survival in this patient population treated with these regimens.
  • Compare the quality of life during the treatment period and after failure in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, performance status (0 vs 1), and liver involvement (yes vs no). Patients are randomized to one of three treatment arms.

  • Arm I: Patients receive epirubicin IV bolus and cisplatin IV over 4 hours on day 1 plus fluorouracil IV continuously on days 1-21.
  • Arm II: Patients receive docetaxel IV over 1 hour and cisplatin IV over 4 hours on day 1.
  • Arm III: Patients receive docetaxel and cisplatin as in arm II and fluorouracil as in arm I.

Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before randomization; at day 1 of courses 2, 4, and 6; and one month after treatment failure.

Patients with complete response or partial response are followed monthly for 3 months.

PROJECTED ACCRUAL: Approximately 111 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004873

Locations
Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Arnaud Roth, MD Hopital Cantonal Universitaire de Geneve
  More Information

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00004873     History of Changes
Other Study ID Numbers: SAKK 42/99, SWS-SAKK-42/99, EU-99021
Study First Received: March 7, 2000
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Epirubicin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 21, 2014