Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer

Sponsor

Swiss Group for Clinical Cancer Research (Other)

Overall Status

Completed

CT.gov ID

NCT00004873

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: cisplatin Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil	Phase 2

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

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.

Study Design

Study Type:

Interventional

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

Study Start Date :

Aug 1, 1999

Actual Primary Completion Date :

Jul 1, 2003

Actual Study Completion Date :

Jul 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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