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AzTrials

Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT01123473

Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer

A Phase 2 study testing capecitabine, cisplatin and epirubicin hydrochloride in people with Adenocarcinoma of the Gastroesophageal Junction and Gastric Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin hydrochloride, cisplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
capecitabine, cisplatin and epirubicin hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
4 sitesin 3 countries
Study dates
Dec 2010to Sep 2014
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the stomach or the esophagogastric junction
  • Metastatic disease OR not amenable to curative surgery
  • Tissue material for HER2 and EGFR assessment must be available
  • Positive HER2 status by immunohistochemistry (IHC) OR positive EGFR by either fluorescence in situ hybridization (FISH) or IHC at time of randomization
  • No clinical signs of CNS involvement

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • WBC > 3 x 10^9/L
  • Absolute neutrophil count > 1.5 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Hemoglobin > 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 3 times ULN (≤ 5 times ULN in case of liver metastases)
  • Serum creatinine ≤ 2.0 mg/dL
  • Creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after completion of study therapy
  • LVEF normal by MUGA scan or ECHO
  • No serious cardiac illness within the past 6 months
  • No previous or concurrent malignancies except for adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • Able to swallow and retain oral medication
  • No history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • No uncontrolled infections or serious illnesses, malabsorption syndrome, or medical conditions including chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule

PRIOR CONCURRENT THERAPY:

  • At least 12 months since prior neoadjuvant or adjuvant chemotherapy
  • No other investigational drugs from 28 days prior to the first dose of study treatment until 30 days after the last dose of study treatment
  • At least 30 days since prior and no concurrent drugs or herbal constituents known to be inducers or inhibitors of CYP3A4
  • No prior palliative systemic chemotherapy
  • No prior EGFR pathway-targeting therapy (e.g., antibodies or tyrosine kinase inhibitors)
  • No concurrent traditional Chinese medicines
  • No concurrent non-drug therapies such as radiotherapy (other than for pain relief) or surgery
  • No other concurrent anticancer therapy or investigational agents
  • No concurrent grapefruit or its juice

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Belgium2 sites

  • Institut Jules Bordet

    Brussels

  • U.Z. Gasthuisberg

    Leuven

Other trials in Belgium

Germany1 site

  • Johannes Gutenberg Universitaetskliniken

    Mainz

Other trials in Germany

Portugal1 site

  • I.P.O. Francisco Gentil - Centro De Lisboa

    Lisbon

Other trials in Portugal

About this study

Official title: Effectiveness of First Line Treatment With Lapatinib and ECF/X in Histologically Proven Adenocarcinoma of the Stomach or the Esophagogastric Junction, Metastatic or Not Amenable to Curative Surgery According to HER2 and EGFR Status: a Randomized Phase II Trial

RATIONALE: Drugs used in chemotherapy, such as epirubicin hydrochloride, cisplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving combination chemotherapy together with or without lapatinib ditosylate is more effective in treating patients with cancer of the stomach or gastroesophageal junction.

PURPOSE: This randomized phase II trial is studying how well epirubicin hydrochloride, cisplatin, and fluorouracil or capecitabine works when given together with or without lapatinib ditosylate as first-line therapy in treating patients with stomach cancer or gastroesophageal junction cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the activity of first-line treatment comprising epirubicin hydrochloride, cisplatin, and fluorouracil or capecitabine with or without lapatinib ditosylate in patients with adenocarcinoma of the stomach or esophagogastric junction that is metastatic or not amenable to curative surgery according to HER2 and EGFR status.

Secondary

  • To explore the activity of this regimen in patients who are HER2 negative by FISH, but HER2 positive by IHC (2+ and 3+) as well as patients who are HER2 positive or negative by FISH and negative by IHC (0 or 1+), but EGFR positive by FISH or by IHC (2+ and 3+).
  • To assess the concordance of HER2 determination by FISH and IHC.

OUTLINE: This is a multicenter study. Patients are stratified according to institution and the combination of EGFR/HER2 status as determined by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) assays (HER2 positive by FISH/HER2 positive by IHC 2/3+ vs HER2 negative by FISH/HER2 positive by IHC 2/3+ vs HER2 negative by IHC 0/1+/EGFR positive by FISH or by IHC 2/3+). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (experimental): Patients receive epirubicin hydrochloride IV and cisplatin IV on day 1; fluorouracil IV continuously on days 1-21 or oral capecitabine twice daily on days 1-21; and oral lapatinib ditosylate once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (control): Patients receive epirubicin hydrochloride, cisplatin, and fluorouracil or capecitabine as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 8 weeks, every 3 months for 2 years, and then every 6 months thereafter.

Being tested
capecitabine, cisplatin, epirubicin hydrochloride, fluorouracil, lapatinib ditosylate
Keywords
adenocarcinoma of the gastroesophageal junction, adenocarcinoma of the stomach, stage IIIA gastric cancer, stage IIIB gastric cancer, stage IIIC gastric cancer, stage IV 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.

Study groups in NCT01123473
Study groupRoleWhat they receive
LapatinibExperimentalChemotherapy + lapatinib
Receives: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: lapatinib ditosylate
PlaceboPlacebo comparatorChemotherapy + placebo
Receives: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

Secondary outcomes (4)

  1. Response rate

  2. Overall survival

  3. Toxicity

  4. Concordance of diagnostic tests

Timeline

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

  1. First posted14 May 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2013
  4. Study completionSep 2014

Why it stopped: company withdrew interest

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
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01123473
Sponsor's protocol ID
EORTC-40071
Other IDs
EU-21036, 2009-011580-36, 2009
Status last verified
Oct 2016
First submitted
13 May 2010
Last updated
12 Oct 2016
Results posted
No

Publications

  • Roth A, Moehler MH, Mauer M, et al.: Lapatinib in combination with ECF/x in EGFR1 or HER2-overexpressing first-line metastatic gastric cancer (GC): A phase II randomized placebo controlled trial (EORTC 40071). [Abstract] J Clin Oncol 28 (Suppl 15): A-TPS205, 2010.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine, cisplatin and epirubicin hydrochloride in people with Adenocarcinoma of the Gastroesophageal Junction and Gastric Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in 3 countries.

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: stopped early, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Germany, Portugal. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: company withdrew interest). Results are not available in the source record.

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.

What does the primary outcome measure?

Progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01123473, 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 12 Oct 2016.

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