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Gastric CancerPhase 2NCT00004873

Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer

A Phase 2 study testing cisplatin, docetaxel and epirubicin hydrochloride in people with Gastric Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
cisplatin, docetaxel and epirubicin hydrochloride
How many people
Not given
Where
1 siteSwitzerland
Study dates
Aug 1999to Jul 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Hopital Cantonal Universitaire de Geneva

    Geneva, CH-1211

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Gastric Cancer
Being tested
cisplatin, docetaxel, epirubicin hydrochloride, fluorouracil
Keywords
stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 1999
  3. Primary completionJul 2003
  4. Study completionJul 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004873
Sponsor's protocol ID
SAKK 42/99
Other IDs
SWS-SAKK-42/99, EU-99021
Status last verified
May 2012
First submitted
7 Mar 2000
Last updated
15 May 2012
Results posted
No

Publications

  • 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.

    PubMed 17664469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, docetaxel and epirubicin hydrochloride in people with Gastric Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.

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