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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

Phase 2
18 Years
70 Years
Not Enrolling
Gastric Cancer

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Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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



- 18 to 70

Performance status:

- 0-1

Life expectancy:

- Greater than 12 weeks


- WBC count at least 4,000/mm^3

- Platelet count at least 100,000/mm^3


- 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


- BUN normal

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No severe hypercalcemia


- 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


- 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


- 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


Biologic therapy:

- Not specified


- 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


- Not specified


- See Disease Characteristics


- No other concurrent experimental drugs

- No other concurrent anticancer therapies

- At least 30 days since treatment in prior clinical trial

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Arnaud Roth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Cantonal Universitaire de Geneve


Switzerland: Swissmedic

Study ID:

SAKK 42/99



Start Date:

August 1999

Completion Date:

July 2003

Related Keywords:

  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • Stomach Neoplasms